Evenity finally wins EU approval; US-China biologics CDMO raises $60M
→ Amgen and partner UCB have managed to convince the EMA to finally approve their bone-building drug, Evenity, to treat osteoporosis. The drug, which was originally slapped with a negative recommendation by the EU regulator, was tested in three late-stage studies. Data showed the drug was effective, but serious CV adverse events were observed in one trial — triggering regulatory concern in the United States and Europe. The FDA granted Evenity approval in April, but the manufacturers view the EU as the least valuable region in terms of Evenity, Credit Suisse analysts wrote in a note in June, predicting modest EU sales and estimating the EU opportunity is worth $1-2 per share.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
