Traditional Drug Pipeline Monthly Update: July 2023

This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate article for pipeline information on specialty drugs.

New Drug Information

• Suflave^® (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride): The FDA has approved Braintree Laboratories’ Suflave for colonoscopy preparation in adults. Suflave is, a low-volume, colonoscopy preparation – with a taste similar to a lemon-lime sports drink. The approval was based on two randomized, single-blind, active-controlled, multicenter trials that evaluated the efficacy and safety of Suflave in adults undergoing colonoscopy for colorectal cancer screening and surveillance, or diagnostic colonoscopy compared to an FDA-approved comparator. The primary endpoint was the proportion of patients with successful bowel preparation, defined as a preparation rated as excellent or good by the blinded endoscopist on a 4-point scale. Findings from Studies 1 and 2 showed that 93% and 94% of patients who received Suflave, respectively, achieved overall cleansing success compared with 89% of patients who received active comparator in Study 1 (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution) and 94% of patients who received active comparator in Study 2 (sodium sulfate, potassium sulfate, and magnesium sulfate oral solution).¹ Suflave is supplied in a carton containing 2 bottles and 2 flavor enhancing packets. Each bottle contains a white powder for reconstitution and is lemon-lime flavored. The product is expected to be available in early August with pricing to follow.

 Generic Drug Information

• Aggrastat^® (tirofiban/nacl IV soln 5 mg/100 mL-0.9%, 12.5 mg/250 mL-0.9%): Nexus has launched their version of Medicure’s Aggrastat indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). Aggrastat generated $14 million in U.S. annual sales in 2022.

New Indications

• Leqvio^® (inclisiran): The FDA has expanded the indication for Novartis’ Leqvio (inclisiran) to include treatment of adults with high LDL-C and who are at increased risk of heart disease.
• Liletta^® (levonorgestrel): The FDA approved an expanded indication for Allergan’s Liletta to include the treatment of heavy menstrual bleeding for up to five years in patients who choose intrauterine contraception as their method of contraception.
• Opill^® (norgestrel 0.075mg): The FDA has approved HRA Pharma’s Opill (norgestrel 0.075mg), a progestin-only daily oral contraceptive, for over-the-counter (OTC) use for all ages. Opill is the first birth controltablet available over the counter in the U.S. In May 2023, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) voted unanimously 17 to 0, with no abstentions, that the benefits of making Opill^® available for OTC use, outweigh the risks. Opill will be available in stores and online at leading retailers across the U.S. early in the first quarter of 2024 with pricing to follow.

References

1. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information