In Major Breakthrough, FDA Approves First Treatment For Ebola
With the approval, there are now both a vaccine — Merck’s Ervebo — and a therapeutic to battle Ebola Zaire, one of the deadliest infections known to humankind. The treatment, Inmazeb, is an antibody cocktail made by Regeneron Pharmaceuticals, the same company that is developing a monoclonal antibody treatment for COVID that was given to President Donald Trump this month.
The Hill:
FDA Approves First Ebola Treatment
The U.S. Food and Drug Administration (FDA) on Wednesday approved the world’s first successful treatment for the Ebola virus, a major step against one of the world’s deadliest pathogen. The FDA gave its formal blessing to Inmazeb, a mixture of three monoclonal antibodies produced by the American pharmaceutical company Regeneron, after a trial among 382 adult and pediatric patients in the Democratic Republic of the Congo. (Wilson, 10/14)
Stat:
First Ebola Therapy Approved By The FDA
For the first time, an Ebola therapy has been approved for use. The Food and Drug Administration on Wednesday approved Inmazeb, an antibody cocktail made by Regeneron Pharmaceuticals. With the approval, there are now both a vaccine — Merck’s Ervebo — and a therapeutic to battle Ebola Zaire, tools that for decades were out of reach for Ebola, which is one of the deadliest infections known to humankind. There is currently an outbreak in the Democratic Republic of the Congo, the third in the last three years in that country. (Branswell, 10/14)
In other pharmaceutical and biotech news —
Stat:
Vertex Shelves Experimental Rare Lung Disease Drug
Vertex Pharmaceuticals said Wednesday that it has shelved an experimental drug to treat a rare, inherited lung disease due to liver toxicity reported in a mid-stage clinical trial. The discontinuation of the drug, called VX-814, is a rare clinical development setback for Vertex, which has strung together a long list of successful treatments for cystic fibrosis. (Feuerstein, 10/14)
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AstraZeneca Loses First-Of-Its-Kind Lawsuit Filed By Dutch Insurer Over Patent Maneuver
After a two-year battle, a Dutch health insurer has won a lawsuit that accused AstraZeneca (AZN) of creating an unfair monopoly for one of its most popular medicines by relying on an invalidated patent to thwart lower-cost competition. At issue was a patent for the antipsychotic tablet Seroquel, which the District Court of the Hague ruled AstraZeneca used to charge “unjustifiably” high prices to health insurers. (Silverman, 10/14)
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Advocacy Groups Urge WTO To Waive IP Rights To Covid-19 Drugs, Vaccines
Amid growing concern over access to Covid-19 medical products, hundreds of advocacy groups are urging the World Trade Organization to waive some provisions in a trade deal governing intellectual property rights so drugs and vaccines can be more easily obtained, especially by low-income countries. Earlier this month, the South African and Indian governments proposed that a WTO council, which is meeting this week, waive some rules for patents, industrial designs, copyrights, and protection of trade secrets. And their proposal argued the waiver “should continue until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity” to the coronavirus. (Silverman, 10/14)
