LatisseTreatment for Hypotrichosis of Eyelashes
Update: Latisse Now FDA Approved - December 24, 2008
FDA Advisory Committee Recommends Approval of Latisse
FDA Advisory Committee Unanimously Recommends Approval of Latisse (Bimatoprost Solution 0.03%) as a Treatment for Hypotrichosis of Eyelashes
IRVINE, Calif.--(BUSINESS WIRE)--Dec 5, 2008 - Allergan, Inc. today announced the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (9-0) to recommend that the FDA approve Latisse (bimatoprost solution 0.03%) as a treatment for hypotrichosis (or reduced amount of hair) of the eyelashes. If approved, Latisse would be the first and only FDA-approved pharmaceutical to enhance eyelash prominence.
"Today's Advisory Committee recommendation is an important step in the FDA review process to provide consumers with a safe and effective treatment to improve the length, thickness and darkness of natural eyelashes," said Scott Whitcup M.D., Allergan's Executive Vice President of Research and Development. "Recently, unapproved eyelash products containing active drug ingredients have appeared on the market. If approved, Latisse will offer consumers an FDA-approved product which has been extensively studied in well-controlled clinical trials, is manufactured to pharmaceutical standards, is appropriately labeled for use, and is regulated as a prescription product."
In addition to its unanimous recommendation for approval of Latisse, the Committee also voted 5-3 (1 abstained vote) in favor of Phase 4 (post-market studies) to assess use in certain patient populations, including patients of younger age and post-chemotherapy patients with loss of eyelashes.
The Committee's recommendation, although not binding, will be considered by the FDA as it contemplates approval for Latisse as a treatment for eyelash growth. If approved by the FDA, Allergan anticipates launching Latisse in 2009.
This press release contains "forward-looking statements," including the statements by Dr. Whitcup and other statements regarding the safety, effectiveness, approval and market potential associated with Latisse. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry, biologic and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; inconsistency of treatment results among patients; potential difficulties in manufacturing; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2007 Form 10-K and Allergan's Form 10-Q for the quarter ended September 30, 2008. Copies of Allergan's press releases and additional information about Allergan are available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential – to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,500 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.
Contact: Allergan Contacts
Caroline Van Hove (714) 246-5134 (media)
Heather Katt (714) 246-6224 (media)
Jim Hindman (714) 246-4636 (investors)
Joann Bradley (714) 246-4766 (investors)
Posted: December 2008
- Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse -- First and Only Treatment Approved by the FDA for Hypotrichosis of Eyelashes - December 29, 2008