ATARA Biotherapeutics (ATRA) Receives Positive EMA Opinion on Orphan Drug Designation for CMV-CTL Product Candidate
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Atara Biotherapeutics, Inc. (Nasdaq: ATRA) today announced that the European Medicines Agency (EMA) issued a positive opinion for orphan drug designation for the Company's CMV-CTL product candidate for the treatment of CMV infection in patients with impaired cell-mediated immunity.
"The positive opinion from EMA to designate CMV-CTLs as an orphan medicinal product in the European Union (EU) demonstrates the compelling need for new treatments to combat this viral infection in patients with few therapeutic options," said Isaac Ciechanover, M.D., President and Chief Executive Officer of Atara Bio. "We look forward to the presentation of additional clinical data at upcoming scientific congresses on the use of CMV-CTL to treat refractory CMV infection in patients who have received an allogeneic hematopoietic cell transplant, and to continuing our discussions with both FDA and EMA on late phase development to support registration of CMV-CTL."
Orphan drug designation in the EU provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating conditions affecting no more than five in 10,000 persons in the EU, and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized procedure for authorizing medicinal products.
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