The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the agency expand its marketing authorization for two drugs from AbbVie (ABBV 0.53%): chronic lymphocytic leukemia (CLL) treatment Venclyxto and hepatitis C drug Maviret.
Venclyxto, which targets a protein called B-cell lymphoma-2, is already approved in Europe to treat CLL patients for whom previous medications have failed, with or without Roche (RHHBY 1.39%) and Biogen's Rituxan.
The new approval, if given, would allow Venclyxto to be used with Roche's Gazyva in CLL patients who haven't previously been treated, expanding the drug's potential market size. The positive opinion was based on data from the CLL14 clinical trial, which showed Venclyxto plus Gazyva helped patients live longer without their cancers progressing compared to Gazyva plus a chemotherapy called chlorambucil.
Maviret is currently approved as a 12-week treatment regimen for patients infected with genotype 3 chronic hepatitis C virus with compensated cirrhosis of the liver, but the approval being sought would shorten the treatment to just eight weeks.
In the Expedition-8 clinical trial, Maviret, which is already approved for an 8-week regimen when treating the other 5 hepatitis C genotypes, cured 95.2% of patients with genotype 3 infections. The approval would make Maviret the only drug approved in the EU for 8-week treatment for all genotypes in patients without cirrhosis or with compensated cirrhosis. That would help Abbvie compete against Gilead Sciences' rival hepatitis C drugs Harvoni and Epclusa.
The European Commission is expected to make its final decisions on those CHMP recommendations in the first half of this year.