The US Food and Drug Administration (USFDA) has granted tentative approval to Lupin Ltd’s Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg, for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune neuromuscular disorder that affects communication between nerve and muscle. This approval allows Lupin to enter the market and offers a major market opportunity, as the reference drug Firdapse had global net sales of $306 million in 2024. The tablets will be manufactured at Lupin’s facility in Goa, boosting the company’s global manufacturing capabilities and commitment to providing affordable medications.
While the tentative approval meets all quality, safety, and efficacy requirements, final approval will depend on the expiration of or resolution of patent or exclusivity rights related to Firdapse. This approval aligns with Lupin’s focus on developing and expanding its presence in the US market. The successful launch of Amifampridine Tablets, 10 mg, will allow Lupin to capitalize on the large market for LEMS treatment, providing a major boost to its business and financials. With this approval, Lupin reinforces its position as a leading player in the global pharmaceutical industry, committed to delivering high-quality, affordable medications to patients worldwide.