FDA Rejects Under-the-skin Tysabri for Relapsing MS

FDA Rejects Under-the-skin Tysabri for Relapsing MS

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FDA Rejects Under-the-skin Tysabri for Relapsing MS

The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of Tysabri (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). “This response from the FDA does not affect the intravenous administration of Tysabri, a well-established high-efficacy treatment with a well-characterized safety profile, which over the last 15 years has treated more than 200,000 people worldwide with relapsing MS,” Maha Radhakrishnan, MD, chief medical officer at Biogen, said…

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