Amneal Pharmaceuticals (AMRX) has secured FDA approval for memantine/donepezil extended-release capsules for Alzheimer's disease and everolimus tablets for a specific type of brain tumor linked to Tuberous Sclerosis Complex (TSC). The FDA also granted tentative approval to rifaximin tablets for treating irritable bowel syndrome with diarrhea (IBS-D). These approvals mark a significant expansion of Amneal's portfolio, offering new treatment options for patients with neurological, oncological, and gastrointestinal conditions.
Memantine/Donepezil for Alzheimer's Disease
The FDA approved memantine/donepezil extended-release capsules (14-10 mg and 28-10 mg) for the treatment of moderate to severe dementia of the Alzheimer's type. This product is a generic version of AbbVie's Namzaric. Amneal has launched the product with 180-day exclusivity. The combination drug leverages memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. Common adverse reactions associated with memantine hydrochloride are headache, diarrhea, and dizziness, while those associated with donepezil include diarrhea, anorexia, vomiting, nausea, and bruising.
Everolimus for Tuberous Sclerosis Complex
Everolimus tablets (2 mg, 3 mg, and 5 mg) received FDA approval for treating Tuberous Sclerosis Complex (TSC)-associated subependymal giant cell astrocytoma (SEGA) in adult and pediatric patients aged one year and older. Referencing Novartis’ AFINITOR DISPERZ, this approval is expected to increase the supply of this oncology product, which currently has limited suppliers. The most common adverse reactions associated with everolimus are stomatitis and respiratory tract infection. In a Phase 3 clinical trial (EXIST-1), the median treatment duration was 52 weeks, with common adverse events including stomatitis and respiratory tract infection.
Tentative Approval for Rifaximin
The FDA granted tentative approval to Amneal's rifaximin 550 mg oral tablets for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. This approval is tentative because the product is currently involved in litigation. Rifaximin references Bausch Health’s XIFAXAN.
Strategic Implications
Andy Boyer, Executive Vice President, Chief Commercial Officer, Affordable Medicines at Amneal, stated, "Amneal’s competitive advantage in the Affordable Medicines business remains our core capabilities to drive innovation at scale across complex categories to expand the breadth and depth of our portfolio. With our 180-day exclusivity on memantine/donepezil, increasing supply for everolimus, and the tentative approval of rifaximin, we are continuing to expand our differentiated portfolio and providing new key therapies for our customers, providers and patients."
