Gossamer Bio Submits NDA for Seralutinib in Pulmonary Arterial Hypertension
Gossamer Bio (GOSS) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of seralutinib, an oral Janus kinase 1/2 inhibitor, for the treatment of pulmonary arterial hypertension (PAH). The submission is supported by data from two clinical trials: the phase 3 PROSERA study and evidence from the earlier phase 2 TORREY trial. Additional supportive analyses were also included in the application. The NDA marks a significant milestone for Gossamer Bio, as seralutinib could become an important treatment option for PAH patients if approved by the FDA. The company is positioning it to address unmet medical needs and potentially compete with existing therapies in this niche market.
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Topics: clinical_trials drug_approval pharma