(Reuters) - European regulators recommended continued use of Ariad Pharmaceuticals Inc’s cancer drug, Iclusig, in its already approved indications to treat certain kinds of leukemia.
However, the European Medicines Agency (EMA) recommended additional warnings in Iclusig’s European product information to minimize the risk of vascular events, Ariad said.
The decision follows a positive recommendation from the EMA’s Pharmacovigilance Risk Assessment Committee, which said earlier this month that the benefits of Iclusig continued to outweigh its risks.
Ariad is well positioned to complete pricing and reimbursement negotiations in Europe, the company said on Friday.
Iclusig is approved for use in chronic myeloid leukemia and acute lymphoblastic leukemia, but has been linked to a risk of blood clots and artery blockage.
Safety concerns led to sales of the drug in the United States being suspended briefly in November 2013. Iclusig was allowed back on the market nearly two months later, but restricted to a smaller group of patients.
The European Commission is expected to issue a final decision on Iclusig in December, which will be valid throughout the European Union.
The company’s shares rose about 2 percent in light premarket trade on Friday.
Reporting by Natalie Grover in Bangalore; Editing by Simon Jennings