But as biologics (complex human-like proteins) are far more complicated to manufacture than powder pills, it is often true that manufacturing facility clearance is every bit as important as a good clinical trial result. That is true, this morning. Merck is going to work swiftly to resolve the observations at the contractor's facility -- and get the facility approved at FDA, as well. Thus this is all largely. . . immaterial. I'd guess that the facility will be green lighted later in Q4, 2024 [Thus the stock is off less than one percent.] Here's the latest, from an overnight presser:
. . .The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo and Merck’s (known as MSD outside of the United States and Canada) patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. . . .
The CRL results from findings pertaining to an inspection of a third-party manufacturing facility. The CRL did not identify any issues with the efficacy or safety data submitted.
Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.
“We will work closely with the FDA and the third-party manufacturer to address the feedback as quickly as possible in order to bring the first HER3 directed medicine to patients with previously-treated EGFR-mutated non-small cell lung cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We remain confident in the ability to develop this medicine to its full potential. . . .”
Now you know -- as we watch Scotusblog, for a flurry of Supreme Court decisions, due in the next ten minutes. Grin.
नमस्ते
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