GlaxoSmithKline
NEWS
On the FDA’s docket this month are two decisions pushed back from 2025, including one for a rare form of obesity and another for dry eye disease.
Instead of joining the increasingly crowded GLP-1 arena, GSK will focus its efforts downstream of obesity—a push currently anchored by its Phase III-ready FGF21 analog efimosfermin alfa for liver fibrosis.
While GSK did not provide a specific reason for returning Wave Life Sciences’ WVE-006, the decision comes after the asset in September 2025 came below analyst expectations in a Phase Ib/IIa AATD study.
Ahead of GSK are Bristol Myers Squibb and Merck, which have already won FDA approvals for subcutaneous formulations of their respective PD-1 blockers Opdivo and Keytruda.
The star of the acquisition, anti-IgE antibody ozureprubart, is being tested as a prophylactic treatment for food allergies, potentially setting up a competition for GSK with Roche’s Xolair.
Though specific data for bepirovirsen remain under wraps, GSK plans to file for approval in the first quarter of 2026.
The Massachusetts biotech will also be eligible to milestone payments, though the exact amount has yet to be disclosed.
The FDA rejected the use of Exdensur, however, for chronic rhinosinusitis with nasal polyps.
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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