Traditional Drug Pipeline Quarterly Update: September 2022

This quarterly 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 articles for pipeline information on specialty drugs, cell/gene therapies and biosimilars.

New Drug Information

• Daxxify^® (daxibotulinumtoxinA-lanm): The U.S. Food and Drug Administration (FDA) has approved Revance’s Daxxify for injection for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults. Approval of Daxxify was based on the Phase 3 clinical trial, SAKURA, which demonstrated 74% of subjects achieved a > two-grade improvement in glabellar lines at week four per both investigator and patient assessment, and 88% achieved > two-grade improvement at week four per investigator assessment.¹ Daxxify had a median duration of six months. Launch and pricing of Daxxify are pending.
• Aponvie^® (aprepitant): The FDA has approved Heron Therapeutics’ Aponvie injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults. Aponvie is a neurokinin-1 (NK1) receptor antagonist that was approved via the 505(b)2 pathway using Merck Sharp & Dohme Corp’s Emend^®as its reference drug. Delivered via a single 30-second IV injection, Aponvie has demonstrated rapid achievement of therapeutic drug levels ideally suited for the surgical setting.² Aponvie launch and price are pending.

Generic Drug Information

• Vascepa® 0.5gm (icosapent ethyl): Teva launched their generic version of Amarin’s Vascepa® 0.5gm (icosapent ethyl), as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia or as an adjunctive therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 mg/dL or higher. In 2020, multiple manufactures launched their generic version of Vascepa 1gm. Both strengths of Vascepa combined generated $1331 million in U.S. annual sales in 2021.
• Revlimid® 2.5, 20mg capsules (lenalidomide cap, 2.5mg, 20mg) : Dr. Reddy’s has launched their generic version of Bristol-Myers Squibb’s Revlimid 2.5, 20mg. Revlimid is a thalidomide analogue indicated for the treatment of patients with: multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities and mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Dr. Reddy’s is eligible for 180-day exclusivity for these strengths. Multiple manufacturers are scheduled to launch in 2023. Revlimid 2.5mg and 20mg capsules generated $815 million in U.S. annual sales in 2021.
• Suprep® (sodium sulfate/potassium sulfate/magnesium sulfate oral soln, 17.5-3.13-1.6 gm/177 mL): Lupin Pharmaceuticals launched their generic version of Braintree Lab’s Suprep, an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. Suprep generated $292 million in U.S. annual sales in 2021.

+Specialty medication