Gilead Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Hepcludex (bulevirtide) for Hepatitis Delta Virus
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending the full marketing authorization for Hepcludex in adults with chronic HDV & compensated liver disease
- The opinion was based on P-III (MYR301) 48wk. study evaluating bulevirtide in 150 patients, showed a positive impact of bulevirtide on PROs with a greater combined virological & biochemical response (45% & 48%) over patients who had not received antiviral treatment (2%). The safety profile was consistent with prior reports with no patients having AE leading to discontinuation of bulevirtide
- Hepcludex will be the only approved treatment for HDV in the EU if granted by the EC. The company also works with multiple regulatory authorities on marketing applications for bulevirtide in other parts of the world
Ref: BusinessWire | Image: Gilead
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