EMA recommended GSK’s Shingrix for marketing authorization

| By | Development of Vaccines, EMA, GSK

GlaxoSmithKline announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Shingrix for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN), the most common and often painful shingles-related complication, in adults aged 50 years or older.

Shingrix is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses, with a two-to-six month interval between doses.

Shingles is caused by reactivation of the varicella zoster virus, the same virus that causes chickenpox. A person’s risk for shingles increases sharply after 50 years of age. Nearly all adults over 50 have the shingles virus dormant in their nervous system, waiting to reactivate with advancing age.

Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: “Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that around one in three people will develop shingles in their lifetime. Shingrix is specifically designed to overcome the age-related weakening of the immune system and is an important step forward in the prevention of shingles.”

Shingrix is the first shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.

A CHMP positive opinion is one of the final steps before Marketing Authorisation is granted by the European Commission. A final decision by the European Commission is anticipated in April 2018.

Shingrix was approved in Canada and the US in October 2017 and has been recommended by the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older. Regulatory reviews of the vaccine are currently underway in Australia and Japan.

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