Reuters: Vertex Pharmaceuticals Inc’s new cystic fibrosis drug Kalydeco was recommended for approval by European regulators on Friday, boosting prospects for a medicine that analysts believe could be a multibillion-dollar seller.
Kalydeco was approved in the United States in January, when it became the first drug to reach the market to treat the underlying cause rather than symptoms of the life-shortening lung disease.
Friday’s green light from the European Medicines Agency means it is likely to be formally approved by the European Commission within a couple of months.
Cystic fibrosis (CF) is a life threatening genetic disorder that affects about 60,000 people in Europe. Kalydeco helps only a small minority of patients with a specific gene mutation, although Vertex is testing drug combinations it hopes will eventually be able to address the larger CF population.
Cystic fibrosis causes the thin layer of mucus that helps keep the lungs free of germs to become thick, clogging airways and leading to infections that damage the lungs.
The average life expectancy for the disease is 37 years, as damage to the lungs progresses, severely limiting the ability to breathe.
Europe’s drug watchdog also recommended a new drug for kidney cancer from Pfizer called Inyta, Almirall’s lung drug aclidinium bromide, Fycompa for epilepsy from Eisai, NovoThirteen for blood disorder from Novo Nordisk, and a new combination diabetes drug Jentadueto from Boehringer Ingelheim and Eli Lilly.