Azzalure anti-wrinkle injection given UK all clear

By Simon Pitman

- Last updated on GMT

Related tags Botulinum toxin

Azzalure, an injectable anti-wrinkle treatment, has been given the go ahead by the UK Medicines and Healthcare products Regulatory Agency.

It is one of only a handful of such products to be approved for marketing in Europe and is now a contender for the ever-popular injectable anti-wrinkle treatment Botox.

The UK market authorisation comes on the back of the collective authorisation of 15 other European countries, opening it up to the vast potential of this huge market.

Targeting the European market

Already available in these markets, the treatment will become available in the UK from the end of the second quarter of this year, where it will tap into a market that has been enjoying 25 per cent annual growth, giving it a value in excess of £20m (€20m).

However, at the end of last year the British government tightened up legislation governing the administration of the procedure, stipulating that only qualified doctors could allow patients to undergo the treatment.

The treatment specifically targets the glabellar lines that define the frown in between the eyebrows, and like Botox, it has been developed as a muscle relaxant using botulinium toxin.

Co-developed with Galderma and Dysport

Azzalure has been co-developed by dermatological pharmaceutical player Galderma and Ispen, which manufactures Type A botulinium toxin, Dysport, for medical purposes.

The approval was given after the companies submitted data on several clinical trials involving more than 2,600 patients, underlining both the efficacy and safety of the treatment.

The company also stressed the fact that safety approval was secured because Ispen has been supplying Dysport to the medical sector for over 20 years.

Known as Reloxin in the US

In the US Ipsen's botulinum toxin product is marketed under the tradename Reloxin after it was approved by the American regulatory authorities last year.

Doctors first began to use Botox in the 1950s to treat facial twitches. The injections comprise tiny amounts of bovine-sourced poisons that were used to freeze the facial muscles and in turn prevent spasms.

However, in administering the treatment it was also discovered that the treatment helped to minimise wrinkling.

Global spread of Botox

Botox started to be used as an anti-wrinkle treatment in the US some ten years ago, since then it has evolved in to a multi-million dollar business.

In the first instance Botox proved to be particularly popular for women in the 40 to 60 age group. However, as it has become more popular, the people taking the treatment have diversified, with as many as 40 per cent of users being male and many individuals starting to use it in their late 20s.

The treatment, which has to be administered by a qualified professional, lasts anything from eight weeks to eight months, depending on how individuals react to the injection.

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