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Leaves are falling, seasons are changing, and the FDA is taking a clinical stance. The cooler breezes aren’t the only refreshing air this week. The FDA made three significant updates recently causing us to stand up and applaud the renewed focus on clinical outcomes and safety. In case you missed it, here is what you need to know!
Drug Removal: Certain non-small cell lung cancer (NSCLC) patients will no longer be treated with Exkivity after discussions with the FDA. Exkivity received accelerated approval in 2021 but has failed to meet the FDA’s confirmatory data requirements. Takenda has agreed to voluntarily withdraw the product from the global market, making it unavailable for continued administration.
Drug Denial: ATTR-CM is a progressive disease leading to heart failure. Alnylam Pharmaceuticals updated a portfolio drug, Onpattro, to treat this increasingly more prevalent disease. The 12-month trial met its statistical endpoints stating this improved patient outcomes. The FDA reviewers questioned the meaningfulness of those results when applied to real world clinical improvement resulting in their denial. Alnylam abandons Onpattro expansion in US as FDA spurns rare heart disease bid | Fierce Pharma
Drug Safety: Ozempic's widespread utilization is a well-known phenominom at this time. Numerous voluntary post marketing cases of potentially life threatening intestinal blocks (known as “ileus”) were reported into the FDA safety database. In response, the FDA took action triggering a clinical alert notifying providers of a required package label update. GLP-1 Agonists Linked to Higher Risk for GI Complications (medscape.com)
Public concerns for drug access appear in all shapes and sizes. Tackling this significant healthcare issue is of utmost importance for our trust in public instutions, healthcare equity and overall improved population health and longevity. Patients should have access to unknown outcomes or safety risks through clinical trial enrollment in which informed consent, specialists and compensation for their scientific sacrifices can be realized. Essentially, employers are paying for the drug manufacturers' clinical trials by releasing these drugs into the market without truly understanding the effectiveness and side effect of new drugs. Clinical trials should focus on clinically meaningful outcomes and capture safety risks in widespread populations. More attention to interventional pharmacoeconomic principals of dosing de-escalation and generic repurposing clinical trials are needed now more than ever. We give three cheers for the FDA’s recent decisions and look forward to many more!
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