(Reuters) – Pfizer Inc said on Friday the European Medicines Agency granted the company a positive recommendation for approval of its treatment for a rare disorder that occurs in patients with cardiomyopathy.
The drug, Vyndaqel, is used to treat patients who suffer from a form of amyloidosis, which is a rare, progressive disease characterized by the abnormal buildup of a protein called amyloid in the body’s organs and tissues.
There are no approved treatments for the condition in the European Union, the company said, adding that the particular form of the disease is life-threatening, with patients living only two to three and a half years following diagnosis.
Vyndaqel was first approved in 2011 in the European Union for the treatment of a form of nervous system disorder and is currently approved in 45 countries, including Japan, and countries in Europe.
The EMA’s recommendation will now be reviewed by the European Commission and a final decision is expected in the coming months, Pfizer said.
Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Rashmi Aich and Anil D’Silva