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Valeant Pharmaceuticals announced yesterday that its acne vulgaris gel ONEXTON has received FDA approval, making it Valeant’s fourth dermatologic drug to be approved this year
Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced yesterday that its gel ONEXTON has garnered approval by the US Food and Drug Administration (FDA). The gel is designed as once-a-day treatment for comedonal (non-inflammatory) and inflammatory acne vulgaris for patients aged 12 and above.
ONEXTON’s approval came on the back of promising results exhibited by the drug in its Phase-III trial. The pivotal trial was conducted on 498 patients suffering from moderate to severe acne. The results showed that ONEXTON had reduced non-inflammatory lesions by 52% on average, compared to 28% achieved by the placebo. Moreover, inflammatory lesions were reduced by 60% on average using ONEXTON, compared to 31% reduction through the placebo.
The percentage of patients treated successfully with ONEXTON stood at 35%, being double of 17% success achieved by placebo treatment. Success of the treatment was defined as “at least 2 grade improvement in the Evaluator Global Severity (EGS) score from baseline”. However, common side effects of the drug include burning sensation, dermatitis contact, pruritus, rash, colitis, and other allergic reactions.
Valeant Chairman and CEO J. Michael Pearson stated: “We are very pleased that the FDA has approved this new dual action medication that gives physicians and patients a new option for the topical treatment of acne vulgaris.”
The drug is endorsed by Dr. Joshhua Zeichner, Director of Cosmetic and Clinical Research at Mount Sinai Hospital. He has described ONEXTON Gel as “an effective topical medication, appropriate for patients with a wide range of acne and has a favorable tolerability profile”. Acne vulgaris is a common skin disease which affects 40-50 million Americans.
Approval of ONEXTON marks the fourth dermatology drug of Valeant to have received an FDA approval this year; three other drugs being Jublia, Retin-A, and Luzu. ONEXTON Gel is expected to be launched in the US market early next year. Valeant previously strengthened its dermatology portfolio in 2011 after the company bought Sanofi SA’s (ADR) (NYSE:SNY) dermatology unit Dermik for $425 million. An addition of these four recently-approved drugs to Valeant’s dermatology portfolio will help the company generate higher revenue from the lucrative acne market, spanning millions.
However, Valeant’s dermatology portfolio might face competition from privately-held Galderma Laboratories L.P.’s acne drug, Differin. Valeant is also expected to face stiff competition from Allergan, Inc.’s (NYSE:AGN) dermatology portfolio, which contains renowned drugs like Avage, Tazorac, and Aczone. The three Allergan drugs generated combined revenue of $141 million in third quarter this year. Had Valeant been successful in its attempt to acquire Allergan, it could have added Allergan’s dermatology portfolio to its own portfolio.
Nonetheless, an approval of Valeant’s four new dermatology products exonerates the company, which faced severe criticism regarding its cost-cutting measures regarding the research and development (R&D) department. Mr. Pearson commented that the approval of Valeant’s drugs by FDA “validate the company’s output-driven approach to R&D”. Valeant’s approach toward R&D had come under a lot of scrutiny when Allergan refused to accept Valeant’s acquisition offer citing that Valeant will sell off Allergan’s R&D department and use the proceeds to clear debts.
