(Reuters) - AMAG Pharmaceuticals Inc (AMAG.O) said Canadian health regulators approved Feraheme, its drug to treat anemia in adults with chronic kidney disease.
Health Canada approved two doses of 510 mg of Feraheme, the company’s key drug, set two to eight days apart.
Last week, AMAG said a single dose of 1,020 mg of the drug, tested in 36 patients, was efficacious and had no serious adverse events.
The U.S.-based company said marketing applications for Feraheme, which received U.S. marketing approval on June 30, 2009, are under review in other regions including Europe.
AMAG’s Chief Executive Frank Thomas said in a statement that the company plans to complete enrollment in a global registration program for broader indication of iron deficiency anemia in early 2012.
In Nov, AMAG announced the departure of its chief executive and cut its workforce by 25 percent to focus on the development and expansion of Feraheme.
According to Health Canada, about 1.9 to 2.3 million people are living with chronic kidney disease, many with iron deficiency anemia, the company said.
Feraheme will be marketed by Takeda Canada Inc, a unit of Japan’s Takeda Pharmaceutical Co Ltd (4502.T) and AMAG will receive a milestone payment of $3 million upon the first commercial sale in Canada.
Lexington, Massachusetts-based AMAG’s shares, which have risen 40 percent since Oct 21, after its shareholders refused to approve its planned acquisition of rival Allos Therapeutics Inc ALTH.O, closed at $19.05 on Friday on Nasdaq.
Reporting by Kavyanjali Kaushik in Bangalore; Editing by Sreejiraj Eluvangal and Joyjeet Das