Johnson & Johnson ($JNJ) and Pfizer ($PFE) are among the developers that have received positive opinions of new drugs under review for EU approval. For Vertex Pharmaceuticals ($VRTX) and partner J&J, the recommendation is the latest development for blockbuster hopeful telaprevir, a hepatitis C treatment.
The EMA's Committee for Medicinal Products for Human Use (CHMP) said today that it has recommended approval of 5 new drugs, the fate of which will ultimately be decided by the European Commission in the coming months. An odds-on favorite to gain EU approval after getting the green light from the FDA, Vertex's telaprevir (which will be marketed in Europe as Incivo) faces competition from Merck's ($MRK) rival HCV drug that has already been cleared for the EU market and will be co-promoted by Swiss drug giant Roche.
The other new drugs to garner the CHMP's backing include the following:
- J&J's Zytiga (abiraterone), which is under review for treating an aggressive form of prostate cancer in combination with prednisone or prednisolone. The FDA approved the potential blockbuster in April and the drug is part of string of successes J&J has had in advancing new medicines to market.
- Vyndaqel (tafamidis), a Pfizer drug for treating patients with an orphan disease called transthyretin amyloidosis, which causes of unhealthy buildup of amyloid protein in the body's tissues. Pfizer picked up the drug in its buyout of FoldRx last year.
- Dexdor (dexmedetomidine), a sedative that is intended for use in hospitals for patients who don't require "deep sedation," according to the EMA committee. Orion is seeking approval of the drug.
- Plenadren (hydrocortisone), DuoCort Pharma's version of the corticosteroid for adrenal insufficiency in adults.
- check out the rest of the CHMP's decisions here