Pharmacy Update Aug 2020
FDA Rejections The Food and Drug Administration (FDA) recently rejected Gilead’s filing for approval of filgotinib for rheumatoid arthritis. With the FDA asking to see data from an ongoing clinical trial, Gilead is unlikely to be able to refile until mid-2021, pushing it further behind its competitors for the Janus Kinase (JAK) inhibitor market. These drugs suppress the immune system to prevent damage to the joints. The FDA rejected BioMarin’s Roctavian for hemophilia A. This expensive gene therapy was expected to revolutionize the treatment of this disease. However, the manufacturer will be required to complete an ongoing …
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