FDA further delays Roche's Actemra over fears the drug may affect natal development and fertility
Basel, Switzerland-headquartered drug major Roche is facing delays for the US approval of its potential blockbuster novel interleukin-6 receptor-inhibiting monoclonal antibody, Actemra (tocilizumab), after the Food and Drug Administration requested further animal trials before the compound could be approved.
The FDA decision comes despite the agency's Arthritis Advisory Committee voting 10 to one in favor of approval in July (Marketletter August 4). The regulator is concerned that Roche's drug may have an affect on peri- and post-natal development, or fertility and is requesting further non-clinical data to support the approval. The firm's shares dropped 1.9% to 165.90 Swiss francs on the news.
Company says it will "work diligently to fulfil the FDA's requirements"
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