The European Medicines Agency on Friday recommended expanding use of Bavarian Nordic’s smallpox vaccine to protect adults against monkeypox, as well as approvals of 11 other medicines in the EU.
The drugmaker’s vaccine, a weakened form of the vaccinia virus sold as Imvanex in Europe and Jynneos in the U.S., has been approved in the EU for smallpox since 2013.
“The extension of the label will help to improve access to the vaccine throughout Europe and strengthen the future preparedness against monkeypox,” Bavarian Nordic CEO Paul Chaplin said in a statement.
Limited supply has confined use of Bavarian Nordic’s vaccine to individuals who’ve recently been in close contact with an infected person. But the company has received orders for millions of doses and has tapped a U.S.-based contract manufacturer to increase capacity. It expects to deliver to the U.S. nearly 7 million vaccine doses in 2022 and 2023, including 1 million doses this year.
The U.S. has approved and stockpiled a second smallpox vaccine, ACAM2000, but side effects have limited its use. Moderna is researching a monkeypox vaccine but development will take time.
Separately, the EMA recommended approvals for Eli Lilly’s new diabetes drug Mounjaro, Bristol Myers Squibb’s cancer immunotherapy Opdualag and Alnylam Pharmaceuticals’ rare disease treatment Amvuttra, among other recommendations that will now go to the European Commission for market authorization.
The approval of Mounjaro follows the Food and Drug Administration clearing it in Type 2 diabetes in May, setting it up as a rival to Novo Nordisk’s Ozempic. Lilly hopes to also win clearance for the medicine in obesity, where Novo also sells a competing product called Wegovy.
The regulator recommended use of Opdualag for melanoma, following U.S. approval in March.
The drug combines Bristol Myers’ immunotherapy Opdivo with a new antibody medicine that targets the protein LAG-3. Clinical trials have indicated the combination may be less toxic than a widely used combination of Opdivo with an older Bristol Myers drug called Yervoy.
The positive recommendation of Amvuttra for the rare genetic disease transthyretin amyloidosis comes a month after the U.S. approved it. The drug is viewed by analysts as crucial to helping its maker, Alnylam, become sustainably profitable.
The EMA moved ahead of the FDA, however, in endorsing conditional approval of Tecvayli, a multiple myeloma drug from Johnson & Johnson that the company has submitted to the U.S. regulator as well. The medicine is a dual-pronged antibody drug that could be a convenient alternative to recently approved cell therapies for myeloma, among them a treatment J&J co-developed with Legend Biotech.
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