FDA OFFICIAL: NO, US STEPS IN, DRAGS OFF MYSELIS FROM AGREEMENT
In a legal memorandum released Monday, Merck (MRK) LLC requested the European Medicines Agency (EMA) to approve its CoVID-19 pill for the treatment of adults with metastatic melanoma. The EMA cannot agree to the first-in-class pill. The blockbuster Merck’s current melanoma drug, Keytruda, was docked by the U.S. Food and Drug Administration in June, after the agency said the drug wasn’t effective in treating breast cancer patients.
Merck argued that Keytruda didn’t cause as much harm as drugs used to treat breast cancer. The drug’s manufacturer said in a blog post that Merck would discontinue its breast cancer program following its rejection.
“The EU approval of Keytruda and CoVID-19 will also not impact its ongoing breast cancer program in the U.S., where the important tumor types of breast, ovarian, and stomach cancers have not been approved in the EU and need to be explored further,” the company said in its blog post.
Merck’s PD-1 inhibitor, Keytruda, is a blockbuster drug. The company claims that the drug can reduce the risk of overall survival in breast cancer patients.
“The Phase 3 clinical trial results showed that in combination with an anti-PD-1 therapy, including a checkpoint inhibitor, a large majority of patients had a median overall survival (OS) benefit and a minimum significant reduction in disease activity compared to those treated with a chemotherapy alone,” the company said in its blog post.
The EMA’s decision is subject to three appeal processes.
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Merck (MRK) is a global biopharmaceutical company whose product portfolio includes drugs for the treatment of serious conditions such as asthma, ulcerative colitis, hepatitis C, osteoporosis, diabetes, diabetes management, heart failure, fibrosis, and rheumatoid arthritis.