- The committee that recommends whether drugs should be approved in Europe is putting its support behind eight new medicines, including an anemia pill that has attracted much attention and scrutiny in the U.S.
- The pill, known as roxadustat, was developed by California-based FibroGen. For years, FibroGen said its drug was as safe, and sometimes safer, than the standard medicine it was compared to in clinical studies of certain people with chronic kidney disease. This April, however, the company revealed those safety results weren't accurate, a disclosure which has damaged its credibility.
- Despite the controversy, the European Medicines Agency has taken a "positive opinion" of the pill, which would be sold under the brand name Evrenzo and marketed by FibroGen's development partner, Astellas. Alongside Evrenzo, the EMA recommended the European Commission approve Abecma, a cell therapy for hard-to-treat multiple myeloma, Voxzogo, a treatment for achondroplasia, and Bimzelx, a drug for plaque psoriasis.
Europe is a prized market for most drug companies. But getting there requires support from the EMA.
The agency's latest recommendations set up eight medicines for approval, though they still need to be authorized for use by the European Commission.
For FibroGen and Astellas, an approval could help offset some of the trouble Evrenzo recently ran into. The Food and Drug Administration was supposed to decide whether to greenlight the pill by March 20. But just weeks before, FibroGen disclosed that the FDA wanted to hear from outside experts first before making its choice. A meeting of those experts is scheduled for July 15.
Then, in April, FibroGen executives said they recently learned of after-the-matter changes made to the clinical trial data supporting Evrenzo — changes which made the drug appear safer than it would have under the company's original analysis plan.
The updates have shaken investor confidence in FibroGen and its drug, as reflected in the company's stock, which has dropped 45% since the start of March. FibroGen shares were trading at $28 apiece Friday morning, down about 4% from Thursday's market close.
Still, there's a large opportunity awaiting FibroGen and Astellas should they resolve the issues surrounding their drug. According to Evaluate Pharma, the consensus among sellside analysts is that Evrenzo could fetch $2.6 billion in annual sales in 2026.
There are also high expectations for Bimzelx, an anti-inflammatory agent developed by the Belgium-based drugmaker UCB.
Last year, UCB unveiled results from a large study that pitted Bimzelx, also known as bimekizumab, directly against Cosentyx, the top-selling product of Swiss pharmaceutical giant Novartis. The results showed that Bimzelx beat Cosentyx on the study's main measure: complete skin clearance in people with moderate to severe plaque psoriasis. Analysts expect UCB's drug to also generate $2.6 billion in annual sales by 2026, according to Evaluate Pharma.
Bristol Myers Squibb's cellular therapy Abecma, which was recently approved in the U.S., now has backing from the EMA too, as a treatment for adults with relapsed and refractory multiple myeloma who have received at least three previous therapies and whose cancer worsened since receiving their last treatment.
The EMA also had positive opinions of BioMarin Pharmaceutical's Voxzogo; MorphoSys' Minjuvi, for relapsed or refractory diffuse large B‑cell lymphoma; Biogen's Byooviz, a biosimilar version of the eye drug Lucentis; as well as two generic medicines from Mylan.