Kiniksa Announces U.S. Orphan Drug Designation for Mavrilimumab for the Treatment of Giant Cell Arteritis

About this update from Kiniksa Pharmaceuticals International, Plc

[{"type":"text","content":"Management to present at the Morgan Stanley 18th Annual Global Healthcare Conference on Wednesday, September 16th at 2pm EDT\nHAMILTON, Bermuda, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to mavrilimumab for the treatment of giant cell arteritis (GCA). Mavrilimumab is a monoclonal antibody inhibitor targeting granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα).\n “We are pleased to announce that the FDA granted Orphan Drug designation to mavrilimumab for the treatment of GCA,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “Data from our Phase 2 study of mavrilimumab in GCA are expected in the fourth quarter of this year.” There will be a live webcast of Kiniksa’s presentation at the Morgan Stanley 18th Annual Global Healthcare Conference on Wednesday, September 16th at 2:00 p.m. Eastern Daylight Time. The company will provide an update on key activities relating to rilonacept, mavrilimumab, vixarelimab and KPL-404. The presentation will be accessible through the Investors & Media section of the company’s website (www.investors.kiniksa.com). A replay of the webcast will be available on Kiniksa’s website for 14 days following the conference. About Orphan Drug DesignationThe FDA grants Orphan Drug designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the U.S. at the time of designation. Orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user‑fee waivers. If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication for seven years from the date of such approval, except in limi...

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