Despite being approved by the FDA and EMA, Bayer’s Vitrakvi has been turned down by health regulators in Germany and England.
Germany’s medicines assessment group, IQWiG, which helps determine the prices of drugs, criticized the lack of data comparing Vitrakvi to a control group that did not receive the drug. But Bayer said that because Vitrakvi, which was developed to target tumors anywhere in the body, treats such a rare genetic mutation, the company was not able to create a control group.
England health officials, meanwhile, were turned off by the price of the drug — $19,600 for a 30-day supply.
With its U.S. and EU approvals in the bag, Bayer is still expecting to rake in $836 million in peak sales for Vitrakvi. But the news that it is not approved in Germany — Europe’s largest pharma market — is still a setback for the company, which is expecting to lose revenue from its two bestsellers — Xarelto and Eylea — coming off patent within the next few years.
Read the Reuters report.
