Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for the kinase inhibitor Aliqopa (copanlisib) with the US Food and Drug Administration (FDA). Aliqopa, which received accelerated approval in 2017 for the treatment of relapsed follicular lymphoma (FL), failed to meet the primary endpoint of progression-free survival (PFS) benefit in a confirmatory Phase III study, a critical requirement for maintaining its approval.
Impact on Global Markets
The drug’s approval status in China and Taiwan, where it is also indicated for the same use, may follow a similar path due to the missed study endpoint. Bayer has acknowledged the setback and is now considering alternative access options for patients who have responded well to Aliqopa. However, the company has clarified that no new prescriptions for the medicine should be issued moving forward.
Exploring Patient Access Options
Despite the withdrawal of the FDA filing, Bayer remains committed to exploring options that may allow continued access to Aliqopa for patients who have experienced positive outcomes while on the treatment. This commitment underscores Bayer’s ongoing dedication to patient care, even as the company navigates the challenges presented by the recent study results.- Flcube.com
