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Allergan plc passes Japanese Ministry of Health, Labour and Welfare's approval for additional use of BOTOX Vista in crow's feet lines.

M2 EQUITYBITES-May 24, 2016-Allergan plc passes Japanese Ministry of Health, Labour and Welfare's approval for additional use of BOTOX Vista in crow's feet lines


Pharmaceutical company Allergan plc (NYSE:AGN) revealed on Monday that it has been granted Japanese Ministry of Health, Labour and Welfare approval for an additional use for BOTOX Vista (botulinum toxin type A product) as a treatment for crow's feet lines (CFL).

The company said BOTOX Vista is now indicated for the temporary improvement in the appearance of lateral canthal lines (CFL) in adult patients under the age of 65. This marketing authorisation is specific to its botulinum toxin type A product.

This approval for BOTOX Vista to treat CFL is based on the company's phase 3 clinical study in Japan involving 300 patients. Of the patients who received a single dose of BOTOX Vista at 12 units or 24 units, over 56.5% and 68.3% respectively achieved an improvement of the appearance of CFL at day 30, compared to those patients who did not receive botulinum toxin type A treatment (8.2% with placebo).

Under the company's second phase 3 study, the patients received concurrent treatment of CFL (12 units or 24 units) and glabellar lines (20 units) with BOTOX Vista in up to four treatment cycles.

In conjunction, the BOTOX product was first approved for therapeutic use by the US FDA in 1989, making it the first botulinum toxin type A product to be approved in the world. It is recognized as an effective treatment for 26 indications in 94 countries worldwide and is in clinical development for other potential aesthetic uses as well.

BOTOX is a prescription-only medical product that contains tiny amounts of a highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. When injected at the recommended doses into a specific muscle or gland, BOTOX neurotoxin is expected to produce a safe, as well as effective result, usually lasting up to approximately three to 10 months, depending on the approved indication and on the individual patient, concluded the company.

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Publication:M2 EquityBites (EQB)
Date:May 24, 2016
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