Perspectives
Drug Approvals Quarterly Update: July 2024
July 31, 2024This wrap-up provides a review of newly approved drugs, recent drug launches, new indications and news of note on drugs in the approval process.
Traditional drug approvals
Traditional drug approvals – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved* |
| sofpironium | Sofdra™ | Botanix | Primary axillary hyperhidrosis in patients ≥ 9 years of age | Topical | June |
| tadalafil | Chewtadzy™ | Ani | (1) Erectile dysfunction (ED); (2) the signs and symptoms of benign prostatic hyperplasia (BPH); and (3) ED and the signs and symptoms of BPH (ED/BPH) | Oral | June |
| vigabatrin | Vigafyde™ | Pyros | Infantile spasms for whom the potential benefits outweigh the potential risk of vision loss in patients 1 month to 2 years of age (monotherapy) | Oral | June |
| clonidine | Onyda™ XR | Tris | Attention deficit hyperactivity disorder (ADHD) in pediatric patients ≥ 6 years of age | Oral | May |
| mycophenolate mofetil oral suspension | Myhibbin™ | Azurity | Organ rejection prophylaxis in patients ≥ 3 months of age | Oral | May |
| ceftobiprole medocaril | Zevtera® | Basilea | Staphylococcus aureus bacteremia (adults); Acute bacterial skin and skin structure infections (adults); Community-acquired bacterial pneumonia (ages ≥ 3 months) | Intravenous (IV) | April |
| diazepam buccal film | Libervant™ | Aquestive | Acute treatment of intermittent, stereotypic episodes of frequent seizure activity distinct from a patient’s usual seizure pattern in patients 2 to 5 years of age | Oral transmucosal | April |
| naloxone (high-dose) | Rezenopy™ | Summit | Opioid overdose | Intranasal | April |
| pivmecillinam | Pivya™ | Utility Therapeutics | Uncomplicated UTI in adult females | Oral | April |
| valbenazine | Ingrezza® Sprinkle | Neurocrine Biosciences | Huntington’s disease-associated tardive dyskinesia and chorea | Oral | April |
| aprocitentan | Tryvio® | Idosia | Difficult-to-control or resistant hypertension | Oral | March |
| risperidone extended-release injection | Risvan® | Laboratorios Farmacéuticos Rovi | Schizophrenia (adults) | Intramuscular (IM) | March |
| budesonide | Eohilia™ | Takeda | Inflammation caused by eosinophilic esophagitis | Oral | February |
| cefepime/enmetazobactam | Exblifep® | Allecra | Complicated urinary tract infections (UTI) | IV | February |
| iloprost | Aurlumyn™ | Eicos Science/Actelion | Severe frostbite | IV | February |
| letibotulinumtoxinA-wlbg | Letybo® | Hugel America | Glabellar lines | IM | February |
| berdazimer | Zelsuvmi™ | Ligand | Molluscum contagiosum | Topical | January |
New indications for approved traditional drugs – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Month Approved* |
| dapagliflozin | Farxiga® | AstraZeneca | Expanded pediatric indication (ages ≥ 10 years) as adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM) | June |
| dapagliflozin/metformin | Xigduo® XR | AstraZeneca | Expanded pediatric indication (ages ≥ 10 years) as adjunct to diet and exercise to improve glycemic control in patients with T2DM | June |
| lacosamide | Motpoly XR™ | Aucta | Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at ≥ 50 kg | June |
| pitolisant | Wakix® | Harmony | Excessive daytime sleepiness in patients with narcolepsy in patients ≥ 6 years of age | June |
| dolutegravir/lamivudine | Dovato | Viiv | Expanded pediatric indication (ages ≥ 12 years, weighing ≥ 25 kg) for treatment of human immunodeficiency-1 (HIV-1) infection | April |
| iloperidone | Fanapt® | Vanda | Acute treatment of manic or mixed episodes in adults with bipolar I disorder | April |
| alirocumab | Praluent® | Regeneron | Expanded pediatric indication (> 8 years of age) for heterozygous familial hypercholesterolemia | March |
| baloxavir marboxil | Xofluza® | Genentech | Expanded pediatric indication (5 to < 12 years of age) for the tablet and granules for oral suspension formulations for influenza | March |
| bempedoic acid | Nexletol® | Esperion | Reduce the risk of myocardial infarction and coronary revascularization in adults unable to take recommended statin therapy, at high risk or with established cardiovascular disease (CVD) | March |
| bempedoic acid/ezetimibe | Nexlizet® | Esperion | Reduce the risk of myocardial infarction and coronary revascularization in adults unable to take recommended statin therapy, at high risk or with established CVD | March |
| fluticasone propionate | Xhance® | Optinose | Chronic sinusitis including patients without polyps in the nasal cavity | March |
| rilpivirine | Edurant® and Edurant® PED | Janssen | Expanded pediatric indication (2 to 12 years of age, weighing ≥ 25 kg to < 35 kg, treatment-naïve with HIV-1 RNA ≤ 100,000 copies/mL) for HIV-1 infection | March |
| semaglutide | Wegovy® | Novo Nordisk | Higher dose than used in diabetes approved for risk reduction of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction [MI], or non-fatal stroke) in adults with established CVD and obesity or overweight | March |
| tenofovir alafenamide | Vemlidy® | Gilead | Expanded pediatric indication (6 years to < 12 years of age, weighing ≥ 25 kg) for chronic hepatitis B virus infection | March |
| remdesivir | Veklury® | Gilead | Expanded pediatric indication (from birth) for COVID-19 | February |
| ceftazidime/avibactam | Avycaz® | AbbVie | Expanded pediatric indication (birth to < 3 months of age) for certain bacterial infections | January |
Vaccine and immunization new approvals – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved* |
| pneumococcal 21-valent conjugate vaccine | Capvaxive™ | Merck | Active immunization for the prevention of invasive disease caused by certain Streptococcus pneumoniae (ages ≥ 18 years); active immunization for the prevention of pneumonia caused by S. pneumoniae certain serotypes (ages ≥ 18 years) | IM | June |
| Respiratory syncytial virus (RSV) vaccine | mRESVIA® | Moderna | Prevention of RSV-related lower respiratory tract disease (LRTD) in individuals ≥ 60 years of age | IM | May |
New indications for approved vaccines and immunizations – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved* |
| RSV vaccine, adjuvanted | Arexvy | GlaxoSmithKline | Expanded indication (age 50 to 59 years) for the prevention of RSV-associated LRTD who are at an increased risk for the condition | IM | June |
Specialty drug approvals
Specialty drug approvals – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved* |
| immune globulin intravenous, human-dira | Yimmugo® | Grifols Biotest | Primary humoral immunodeficiency in patients ≥ 2 years of age | IV | June |
| crovalimab-akkz | Piasky™ | Genentech | Paroxysmal nocturnal hemoglobinuria (PNH) in patients ≥ 13 years of age | IV, SC | June |
| elafibranor | Iqirvo® | Ipsen | Primary biliary cholangitis | Oral | June |
| ensifentrine | Ohtuvayre™ | Verona | Maintenance treatment of chronic obstructive pulmonary disease (COPD) | Oral inhalation | June |
| imetelstat | Rytelo™ | Geron | Low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia | IV | June |
| mavorixafor | Xolremdi™ | X4 Pharmaceuticals | Warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome | Oral | April |
| danicopan | Voydeya™ | AstraZeneca | PNH with extravascular hemolysis | Oral | March |
| givinostat | Duvyzat™ | ITF | Duchenne muscular dystrophy (DMD) | Oral | March |
| macitentan/tadalafil | Opsynvi® | Johnson and Johnson | Pulmonary arterial hypertension (PAH) | Oral | March |
| resmetirom | Rezdiffra™ | Madrigal | Noncirrhotic nonalcoholic steatohepatitis (NASH) | Oral | March |
| sotatercept-csrk | Winrevair™ | Merck | Pulmonary arterial hypertension (PAH) | SC | March |
| vadadustat | Vafseo® | Akebia | Anemia due to chronic kidney disease (CKD) dialysis-dependent | Oral | March |
New indications for approved specialty drugs -2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Month Approved* |
| efgartigimod alfa/ hyaluronidase-qvfc | Vyvgart® Hytrulo | Argenx | Chronic inflammatory demyelinating polyneuropathy | June |
| risankizumab-rzaa | Skyrizi® | Abbvie | Moderately to severely active ulcerative colitis | June |
| sarilumab | Kevzara® | Sanofi | Active polyarticular juvenile idiopathic arthritis in patients weighing ≥ 63 kg | June |
| belimumab | Benlysta | GlaxoSmithKline | Expanded pediatric indication (≥ 5 years of age) for SC administration for systemic lupus erythematosus | May |
| apremilast | Otezla® | Amgen | Expanded pediatric indication (6 to 17 years of age, weighing ≥ 20 kg) for plaque psoriasis | April |
| benralizumab | Fasenra® | AstraZeneca | Expanded pediatric indication (6 to 11 years of age) for severe asthma | April |
| vedolizumab | Entyvio® | Takeda | Crohn’s disease (adults) | April |
| factor IX, recombinant | Ixinity® | Medexus | Expanded pediatric indication (<12 years of age) for hemophilia B | March |
| maralixibat | Livmarli® | Mirum | Expanded pediatric indication (≥ 5 years of age) for cholestatic pruritus with progressive familial intrahepatic cholestasis (PFIC) | March |
| ravulizumab-cwvz | Ultomiris® | Alexion | Neuromyelitis optica spectrum disorder (anti-aquaporin 4 antibody-positive) | March |
| spesolimab-sbzo | Spevigo® | Boeringer Ingelheim | Generalized pustular psoriasis | March |
| bictegravir/ emtricitabine/ tenofovir alafenamide | Biktarvy® | Gilead | Expanded indication for HIV-1 infection with M184V/I resistance | February |
| omalizumab | Xolair® | Genentech/ Novartis | Reduction of allergic reactions, that may occur with an accidental exposure to one or more foods | February |
| dupilumab | Dupixent® | Sanofi/ Regeneron | Expanded pediatric indication (>1 year of age) for eosinophilic esophagitis | January |
| immune globulin infusion (human) | Gammagard Liquid® | Takeda | Chronic inflammatory demyelinating polyneuropathy | January |
| immune globulin infusion 10% (human)/ recombinant human hyaluronidase | HyQvia® | Takeda | Chronic inflammatory demyelinating polyneuropathy | January |
Oncology drug approvals – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved* |
| thiotepa | Tepylute | Shorla | Adenocarcinoma of the breast or ovary | IV | June |
| tarlatamab-dlle | Imdelltra™ | Amgen | Extensive stage small cell lung cancer (SCLC) with progression on or after platinum-based chemotherapy | IV | May |
| nogapendekin alfa inbakicept-pmln | Anktiva® | ImmunityBio | Use in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) | Intravesically | April |
| tovorafenib | Ojemda™ | Day One | Relapsed or refractory (R/R) pediatric low-grade glioma with BRAF fusion or rearrangement or BRAF V600 mutation in patients ≥ 6 months of age | Oral | April |
| tislelizumab-jsgr | Tevimbra® | BeiGene | Esophageal squamous cell carcinoma | IV | March |
New indications for approved oncology medications – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Month Approved* |
| adagrasib | Krazati® | Mirati | KRAS G12C-mutated locally advanced or metastatic colorectal cancer for use in combination with cetuximab | June |
| blinatumomab | Blincyto® | Amgen | CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in patients ≥ 1 month of age | June |
| durvalumab | Imfinzi® | AstraZeneca | Primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) | June |
| epcoritamab-bysp | Epkinly™ | Genmab | R/R follicular lymphoma following ≥ 2 prior lines of therapy | June |
| pembrolizumab | Keytruda® | Merck | Primary advanced or recurrent endometrial carcinoma | June |
| repotrectinib | Augtyro™ | Bristol-Myers Squibb | Solid tumors that: (1) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, (2) are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and (3) have progressed following treatment or have no satisfactory alternative therapy in patients ≥ 12 years of age | June |
| selpercatinib | Retevmo® | Eli Lilly | Expanded pediatric indication (2 years to < 12 years of age) for: (1) advanced or metastatic medullary thyroid cancer with a rearranged during transfection (RET) mutation, (2) advanced or metastatic thyroid cancer with a RET gene fusion, and (3) locally advanced or metastatic solid tumors with a RET gene fusion | May |
| alectinib | Alecensa® | Genentech | Non-small cell lung cancer (NSCLC) (ALK+, tumors ≥ 4 cm or node positive, adjuvant therapy) | April |
| fam-trastuzumab deruxtecan-nxki | Enhertu® | Daiichi Sankyo | Unresectable or metastatic, HER2+ solid tumors (≥ 2nd-line) | April |
| inotuzumab ozogamicin | Besponsa® | Pfizer | Relpased or refractory CD22-positive B-cell precursor ALL in pediatric patients 1 year and older | March |
| nivolumab | Opdivo® | Bristol-Myers Squibb | Unresectable or metastatic urothelial carcinoma as first-line in combination with cisplatin and gemcitabine chemotherapy | March |
| ponatinib | Iclusig® | Takeda | Newly diagnosed with Philadelphia chromosome-positive (Ph+) ALL as first-line treatment | March |
| zanubrutinib | Brukinsa® | BeiGene | In combination with obinutuzumab for treatment of adults with relapsed or refractory follicular lymphoma (r/r FL) after at least two prior lines of systemic therapy | March |
| irinotecan liposome | Onivyde® | Ipsen | Metastatic pancreatic ductal adenocarcinoma as first-line treatment | February |
| osimertinib | Tagrisso® | AstraZeneca | Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, for use in combination with pemetrexed and platinum chemotherapy as first-line therapy | February |
| alpelisib | Piqray® | Novartis | Pre- and perimenopausal women for use in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer | January |
| pembrolizumab | Keytruda® | Merck | In combination with chemoradiotherapy for newly diagnosed patients with advanced cervical cancer | January |
| erdafitinib | Balversa® | Janssen | Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations who progressed on or after at least one line of systemic therapy | January |
Biosimilars and gene/cell therapy drug approvals
Biosimilar approvals
| Generic Name | Brand Name | Reference Product | Manufacturer | Indication(s) | Route of Administration | Month Approved* |
| aflibercept-mrbb | Ahzantive™ | Eylea® | Formycon | Macular & retinal disorders | Intravitreal | June |
| filgrastim-txid | Nypozi™ | Neupogen® | Tanvex | Neutropenia; Stem cell mobilization | IV, SC | June |
| ustekinumab-ttwe | Pyzchiva® | Stelara® (provisionally interchangeable) | Sandoz/ Samsung Bioepis | Autoimmune disorders | IV, SC | June |
| aflibercept-jbvf | Yesafili™ | Eylea® | Biocon | Macular & retinal disorders | Intravitreal | May |
| aflibercept-yszy | Opuviz™ | Eylea® | Samsung Bioepis/ Biogen | Macular & retinal disorders | Intravitreal | May |
| eculizumab-aeeb | Bkemv™ | Soliris® (interchangeable) | Amgen | Paroxysmal nocturnal hemoglobinuria; Atypical hemolytic uremic syndrome | IV | May |
| trastuzumab-strf | Hercessi™ | Herceptin® | Accord | Breast cancer (HER2+); Gastric cancer (HER2+) | IV | April |
| ustekinumab-aekn | Selarsdi™ | Stelara® | Alvotech/ Teva | Plaque psoriasis (ages ≥ 6 years); Psoriatic arthritis (ages ≥ 6 years) | SC | April |
| denosumab-bbdz | Jubbonti® | Prolia® (interchangeable) | Sandoz | Bone health | SC | March |
| denosumab-bbdz | Wyost® | Xgeva® | Sandoz | Bone health | SC | March |
| tocilizumab-aazg | Tyenne® | Actemra® | Fresenius Kabi | Autoimmune disorders | IV, SC | March |
| adalimumab-ryvk | Simlandi® | Humira® (interchangeable of high concentration [100 mg/mL citrate-free]) | Alvotech/ Teva | Autoimmune disorders | SC | February |
New indications for approved biosimilars – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Month Approved* |
| adalimumab-adbm (100 mg/mL) | Cyltezo® | Boehringer Ingelheim | Autoimmune disorders (new formulation) | April |
| pegfilgrastim-bmez | Ziextenzo® | Sandoz | Hematopoietic subsyndrome of acute radiation syndrome | February |
Gene/cell therapy approvals – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Month Approved* |
| fidanacogene elaparvovec-dzkt | Beqvez™ | Pfizer | Hemophilia B without AAVRh74var capsid neutralizing antibodies | IV | April |
| atidarsagene autotemcel | Lenmeldy™ | Orchard | Early-onset metachromatic leukodystrophy | IV | March |
| lifileucel | Amtagvi™ | Iovance | Unresectable or metastatic melanoma | IV | February |
New indications for approved gene/cell therapy products – 2024
| Generic Name | Brand Name | Manufacturer | Indication(s) | Month Approved* |
| delandistrogene moxeparvovec-rokl | Elevidys® | Sarepta | Expanded indication to include ambulatory patients ≥ 4 years of age (full approval) and non-ambulatory patients ≥ 4 years of age (accelerated approval) with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene | June |
| lisocabtagene maraleucel | Breyanzi® | Bristol-Myer Squibb | R/R mantle cell lymphoma (MCL) following ≥ 2 prior lines of systemic therapy; R/Ry follicular lymphoma following ≥ 2 prior lines of systemic therapy | May |
| ciltacabtagene autotemcel | Carvykti® | Janssen | R/R multiple myeloma following ≥ 1 prior line of therapy | April |
| idecabtagene vicleucel | Abecma® | Bristol-Myer Squibb | R/R multiple myeloma following ≥ 2 prior lines of therapy | April |
| lisocabtagene maraleucel | Breyanzi® | Bristol-Myer Squibb | R/R chronic lymphocytic or small lymphocytic lymphoma following ≥ 2 prior lines of therapy | March |
| exagamglogene autotemcel | Casgevy® | Vertex/ CRISPR | Transfusion-dependent beta-thalassemia | January |
Disclaimer
*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.
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