The FDA's recent approval of Actelion's new pulmonary arterial hypertension (PAH) drug Opsumit provided a huge wave of relief for the Swiss drugmaker. Tracleer accounts for the vast majority of Actelion's ($ATLN) revenues but goes off patent in 2015. Now the drugmaker has further secured a place in the market for its new and improved hypertension treatment with approval from the European Commission.
The Swiss drugmaker said in a statement that the EC approved the drug for use by itself or in concert with another PAH drug. Actelion intends to begin selling it in Europe in February, with Germany first in line to get it. The drugmaker launched Opsumit in the U.S. last month after the FDA approved it in October.
As PMLiVE points out, patients taking Opsumit do not have to be monitored for liver concerns, as they do with Tracleer, which is seen as a boost for the new drug. But Opsumit will be facing a fairly crowded market. It was approved 10 days after the FDA approved Bayer's Adempas, which also was green-lighted for treating a second form of rare pulmonary disorder. Opsumit will also compete with Gilead Sciences' ($GILD) Letairis (ambrisentan) and Pfizer's ($PFE) Revatio, as well as drugs from United Therapeutics ($UTHR). In fact, United Therapeutics said on Monday that the FDA approved its Orenitram (treprostinil, or oral Remodulin) after it had twice turned it down for PAH, FierceBiotech reports.
Actelion needed Opsumit approved and in the market ahead of Tracleer revenues falling off the patent cliff. Tracleer continues to do well, with sales rising 3% to CHF 1.138 billion ($1.26 billion) for the first 9 months of the year. But it accounted for 87% of Actelion's revenues last year, so its patent loss will create a large hole in Actelion's revenues to be filled.
- here's the announcement
- see more from PMLiVE
- read the FierceBiotech story