Biogen Idec issues statement on Novartis MS drug
Swiss drug maker Novartis says it has gained approval from US regulators for a new multiple sclerosis treatment, the AP is reporting out of Geneva.
Novartis, which has a big presence in Massachusetts, says the US Food and Drug Administration has approved Gilenya for oral use with relapsing forms of multiple sclerosis, the AP said.
Gilenya is potential competition for MS drugs made by Biogen Idec Inc. of Weston.
In a press release this morning, Biogen Idec said: "MS impacts each person differently and until we have a cure, there should be multiple treatments available to address the individual needs of patients. Today Biogen Idec is pleased to provide leading MS therapies Avonex (interferon beta-1a) and Tysabri (natalizumab), both of which have been used in a broad range of patients worldwide."
The release added: "The long-term safety profile of Gilenya has yet to be established, and there is limited data for it in patients with certain common comorbidities. We agree with the FDA that there is a need for safety monitoring for Gilenya through a comprehensive Risk Evaluation and Mitigation Strategy (REMS)."
Novartis is one of several major international drug companies to have Boston-area research centers.
A May story in the Globe noted that the Novartis Institutes for Biomedical Research had doubled its workforce to about 2,000 since it opened in the Kendall Square neighborhood of Cambridge.