EMA backs seven therapies, including Merck's Ebola vaccine
The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.
The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.
The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.
Ervebo, whose conditional marketing application has been granted a positive opinion by the EMA, is a genetically engineered, attenuated live vaccine. It has been tested in roughly 16,000 individuals in trials conducted in Africa, Europe, and the United States — and data suggest the vaccine is effective against the Zaire Ebola virus that circulated in West Africa in 2014-2014, as well as the current outbreak in DRC. The vaccine is also under FDA review.
On Friday, the EMA also issued positive recommendations on Eli Lilly’s $LLY diabetes treatment, Baqsimi, which has already secured FDA approval; Melinta’s antibiotic Quofenix — which is sold as Baxdela in the US — for use in acute bacterial skin and skin structure infections; AbbVie’s $ABBV oral JAK1 inhibitor Rinvoq, a potential blockbuster that was approved by the FDA roughly two months ago with a dreaded black box warning; J&J’s $JNJ President Trump-endorsed (and FDA greenlit) pharmaceutical version of the hallucinogenic anesthetic ketamine — Spravato — for depression; and another biosimilar for Amgen’s $AMGN white blood cell booster Neulasta.
The Netherlands-based agency also changed its mind to back FDA-approved Amgen’s severe postmenopausal osteoporosis medicine, Evenity, after initially issuing a negative opinion last June, citing safety concerns.
Two drugs earned unfavorable decisions.
D&A Pharma’s Hopveus — designed to treat alcohol dependence — was denied the EMA’s backing on grounds that the agency found several drawbacks in the design and analysis of the studies submitted to procure approval. The regulator also took issue with the misuse and abuse potential of the medicine.
Meanwhile, Daiichi Sankyo’s Vanflyta was spurned by the EMA for use in rare cases of acute myeloid leukemia, after the agency underscored that the drug had conferred ‘marginal improvements’ in overall survival and that the main trial used in the marketing applications had ‘important limitations.’ The FDA rejected the drug in June, although Japanese regulators have cleared its use.