EpiDuo Receives FDA Approval to Treat Acne

Galderma Laboratories, L.P., announced the availability of Epiduo (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, the first and only, once-daily, topical acne treatment that combines adapalene and benzoyl peroxide. According to the company, Epiduo will be on pharmacy shelves nationwide in the first quarter of 2009.

According to Galderma, by combining two effective medications into one product, Epiduo Gel treats both inflammatory and non-inflammatory lesions with no evidence of promoting antibiotic resistance, simplifying the management of mild-to-moderate acne. Studies indicate that Epiduo Gel is more efficacious than either of its components used alone and significantly reduces total acne lesions by approximately 18% as early as the first week of treatment.

“By targeting three out of the four causes of acne in a single medication, Epiduo Gel offers doctors and patients an efficacious, easy-to-use tool to tackle mild-to-moderate acne,” said Dr. Linda Stein Gold, director of clinical research and division head of dermatology at Henry Ford Hospital in Detroit, in a company-generated press release.

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FDA Approves Allergan’s Latisse

Allergan recently announced that the FDA has approved Latisse (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. According to Allergan, Latisse is the first and only science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes.

Latisse is a once-daily prescription treatment applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable applicator.

Users can expect longer, fuller and darker eyelashes in as little as 8 weeks, with full results in 16 weeks. Continued treatment is required to maintain the effect.

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FDA Issues Complete Response Letter to Centocor

Centocor, Inc., recently announced that the FDA issued a complete response letter for its biologics license application for ustekinumab. The application, filed by Centocor in late 2007, seeks approval to market ustekinumab as a subcutaneous biologic therapy for the treatment of adult patients with chronic moderate to severe plaque psoriasis.

The complete response letter requests additional information, including a proposal by Centocor for a Risk Evaluation and Mitigation Strategy (REMS). FDA requires REMS to ensure that benefits of an investigational or marketed treatment outweigh the risks. The ustekinumab REMS must contain a Medication Guide and communication plan. It does not require restricted distribution. The FDA has not requested any new non-clinical or clinical studies evaluating the efficacy or safety of ustekinumab prior to approval.

In a company press release, Jerome A. Boscia, MD, senior vice president of Clinical R&D at Centocor, said, “We are confident that we can expeditiously address the questions set forth in the Complete Response letter. We anticipate responding to the FDA in January 2009 and remain focused on bringing ustekinumab to market and ultimately to appropriate patients living with psoriasis and in need of treatment.”

On June 17, 2008, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended ustekinumab for approval.

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FDA Issues Complete Response Letter to Ipsen

France-based pharmaceutical company Ipsen has announced that the FDA has issued a complete response letter for its biologics license application for its botulinum toxin type A, Dysport.

The application, submitted in late 2007, seeks approval to market Dysport for the treatment of cervical dystonia. The FDA has not requested any new clinical studies evaluating the efficacy or safety of Dysport prior to approval. The complete response letter requests additional information, including the finalization of the risk evaluation and mitigation strategy and of the draft labeling, as well as a safety update report.

Furthermore, FDA has confirmed in its Establishment Inspection Report that the manufacturing process for Dysport in its Wrexham (Wales) facility is in compliance with CGMPs.

In a company-issued letter, Stéphane Thiroloix, Ipsen’s Executive Vice President - Corporate Development, said, “We are confident that we can expeditiously respond to the questions set forth in the complete response letter. We anticipate answering to the FDA during the first quarter of 2009 and remain focused on bringing Dysport to market as originally planned.”

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FDA Considers Amending Warning Labels for Indoor Tanning Equipment

Section 230 of the FDA Amendments Act of 2007 requires the FDA to assess the effectiveness of the current labeling requirements for indoor tanning devices, specifically about how well the label conveys information to consumers regarding the risks that such devices pose for the development of irreversible damage to the eyes and skin, including skin cancer. According to the FDA, it is required to conduct consumer testing in making these determinations, and to submit a report to Congress.

Based on its analysis of the results of the consumer study, FDA has determined that “there are warnings that are capable of adequately communicating the risks of indoor tanning, and that a modified warning statement label may more effectively convey these risks than the current labeling requirements.” The FDA’s report further says that changes to the positioning requirements for the warning statement label may communicate such risks more effectively.

As a result, FDA is considering amending the warning label requirements for sunlamp products to include specific formatting requirements that convey the risks that these devices pose for the development of irreversible damage to the eyes and skin, including skin cancer. The FDA says it is also considering amending the performance requirements in the sunlamp products performance standard, and has begun educational outreach efforts to better inform consumers about the risks of indoor tanning.

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Melanoma Research Foundation Responds

In response to the FDA’s report, the Melanoma Research Foundation (MRF) released a statement. The MRF urges the FDA and Congress to act on the report’s findings and amend the 20-year-old labeling requirements so tanning customers clearly understand how damaging indoor tanning and ultraviolet (UV) radiation is to their health.

“We are pleased the FDA was not fooled by recent propaganda encouraging the public to soak up ultraviolet light several times a week because its so-called health benefits,” said Dr. David E. Fisher, Chief of Dermatology at Massachusetts General Hospital and a member of the MRF Scientific Advisory Committee. “Instead, the FDA continues to focus on what the science clearly tells us — UV exposure can cause skin cancer, including melanoma. We encourage the FDA to act on the report’s findings and amend the current labeling requirements so tanning customers clearly understand that indoor tanning represents one of the most striking examples of an avoidable cause of lethal cancers.”