Following the positive opinion, the EC will complete the regulatory process for a final decision on the Marketing Authorisation in early 2018.
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[10-November-2017] |
LEAWOOD, Kan., Nov. 10, 2017 /PRNewswire/ -- Elanco Animal Health, a division of Eli Lilly and Company (NYSE: LLY) and Aratana Therapeutics (NASDAQ: PETX), today announced the European Medicine Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion to recommend the marketing authorization of GALLIPRANT® (grapiprant tablets) in the European Union. Following the positive opinion, the European Commission will complete the regulatory process for a final decision on the Marketing Authorisation in early 2018. Galliprant is a first-in-class veterinary medicine that will be indicated for the treatment of pain associated with mild to moderate osteoarthritis in dogs. Grapiprant, the active ingredient in Galliprant, is a non-steroidal non-cyclooxygenase inhibiting anti-inflammatory drug. Elanco has exclusive rights to develop, manufacture, market and commercialize Galliprant globally, and it co-promotes the product with Aratana in the United States. About Elanco Animal Health About Aratana Therapeutics This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Galliprant, and reflects Lilly, Elanco’s and Aratana’s current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Galliprant will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s and Aratana’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission, respectively. Except as required by law, Elanco and Aratana undertakes no duty to update forward-looking statements to reflect events after the date of this release. Media Contacts Rachel Reiff
View original content:http://www.prnewswire.com/news-releases/elanco-aratana-announce-positive-opinion-on-galliprant-grapiprant-tablets-in-europe-300553682.html SOURCE Aratana Therapeutics, Inc. | ||
Company Codes: NASDAQ-NMS:PETX, NYSE:LLY |