CHMP backs eight new medicines, waiting on remdesivir application

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending the authorization of eight new medicines, including a new vaccine against Ebola virus, and says it is waiting for Gilead Sciences to submit an application for conditional marketing authorization for remdesivir to treat coronavirus disease (COVID-19).
 
The update on the status of remdesivir comes nearly a month after the committee began a rolling review of the drug, and nearly two weeks after EMA Executive Director Guido Rasi told a European Parliament committee the drug could be conditionally authorized “in the coming days.” (RELATED: EMA kicks off rolling review of Gilead’s remdesivir, Regulatory Focus 1 May 2020; Rasi: EMA may conditionally authorize remdesivir in the ‘coming days’, Regulatory Focus 18 May 2020).
 
Following the conclusion of the first cycle of the rolling review on 15 May, CHMP says it requested additional data from Gilead and “agreed that the next step would be for the company to submit this data together with an application for a conditional marketing authorisation.”
 
“The company has not yet submitted an application but is expected to do so shortly,” EMA says, noting that the committee will assess the application in the “absolute minimum” amount of time needed to conduct a thorough evaluation of the benefits and risks of the drug.
 
Recommendations
 
During its meeting, CHMP recommended eight new, generic and biosimilar medicines for marketing authorization.
 
Two of the recommendations are for a vaccine to prevent Ebola virus disease that includes Janssen-Cilag’s Zabdeno (Ad26.ZEBOV-GP [recombinant]) and Mvabea ((MVA-BN-Filo [recombinant]) following an accelerated assessment. The former is administered first, and the latter is given as a booster eight weeks later.
 
CHMP recommended MYR GmbH’s Hepcludex (bulevirtide), the first treatment authorized in the EU for hepatitis D. The drug was accepted to EMA’s Priority Medicines (PRIME) scheme and is being recommended to treat chronic hepatitis D infection in adults with compensated liver disease.
 
There are currently no approved drugs to treat chronic hepatitis D infection in the US, though MYR has received orphan designation and breakthrough therapy designation from the US Food and Drug Administration for bulevirtide.
 
Additionally, CHMP recommended the authorization of Novartis’ Piqray (alpelisib) to treat locally advanced or metastatic breast cancer with a PIK3CA mutation and Nabriva Therapeutics’ Xenleta (lefamulin) to treat adults with community-acquired pneumonia. The committee also recommended the conditional authorization of Roche’s Rozlytrek (entrectinib) to treat patients with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion and patients with ROS1-positive advanced non-small cell lung cancer.
 
The committee also recommended Accord’s trastuzumab biosimilar Zercepac and its generic version of apixaban, as well as new indications for five medicines, Janssen-Cilag’s Invokana (canagliflozin), AstraZeneca’s Lynparza (olaparib), Boehringer Ingelheim’s Ofev (nintedanib), Merck Sharp & Dohme’s  Sivextro (tedizolid phosphate) and Eli Lilly’s Taltz (ixekizumab).