Cosette Pharmaceuticals has achieved a corporate milestone, securing an FDA approval for a legacy Daiichi Sankyo drug in its first nod under the new drug application (NDA) pathway.
The approval is for a liquid formulation of Evoxac, which was originally marketed by Daiichi Sankyo in capsules, providing an alternative treatment option for managing dry mouth symptoms in patients living with Sjögren’s disease.
While the drug was approved under an NDA, Cosette relied partially on existing safety and efficacy data from the legacy capsule formulation through the FDA’s 505(b)(2) pathway. This allowed the New Jersey company to bypass a full-scale clinical development program.
Cosette expects the new oral solution to hit the U.S. market by the end of 2026 and offer a better option for patients who may struggle with swallowing capsules.
“We have built Cosette by acquiring and strengthening trusted brands,” Cosette’s CEO Apurva Saraf said in an Oct. 20 statement. “Today, we are demonstrating that we can also create value through our own product development capabilities.”
Evoxac was part of a multi-product transaction Cosette penned with Daiichi back in 2022, as the Japanese pharma shifted its focus to oncology by shedding some legacy medicines. A portfolio of Daiichi cardiovascular disease therapies—Benicar, Welchol, Azor, Tribenzor and Effient—also found their new home at Cosette. Back then, all those drugs registered annual sales of about $123 million.
Sjögren’s is a systemic autoimmune condition characterized by immune-mediated attacks on moisture-producing glands, leading to debilitating dry eyes and dry mouth alongside fatigue and joint pain.
Existing therapies like Evoxac are approved to manage specific symptoms of Sjögren’s, but no FDA-approved therapies are available to address the underlying autoimmune cause of the disease.
The dry spell in Sjögren’s disease-modifying therapies is ending. Novartis is expecting an FDA decision for ianalumab, its investigational drug targeting the B cell-activating factor (BAFF) receptor, after a pair of phase 3 wins.
Last month, Amgen announced that its dazodalibep, a fusion protein targeting the CD40 ligand, also succeeded in a phase 3 trial in patients with moderate-to-severe Sjögren’s. The company will likely need a second phase 3 win to be able to file for an approval.
Outside the U.S., Chinese authorities approved RemeGen’s telitacicept for Sjögren’s in June, making it the first regulatory approval anywhere for the indication. The BAFF/APRIL dual inhibitor proved its ability to address both systemic disease manifestations and symptoms in a China phase 3 trial. The drug is being developed by Vor Bio outside China, with a global phase 3 in Sjögren’s underway.
In contrast, argenx wasn’t so lucky as its FcRn block Vyvgart Hytrulo suffered a surprise phase 3 failure in Sjögren’s earlier this month.