Drug news
EU CHMP recommends approval of Shingrix for herpes zoster.- GlaxoSmithKline.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Shingrix (zoster virus antigen), from GlaxoSmithkline, intended for prophylaxis of herpes zoster.
Shingrix will be available as a powder and suspension liquid to be made into a suspension for injection. In Shingrix, VZV gE is combined with an adjuvant (AS01B), and is designed to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against varicella zoster virus.
The benefits with Shingrix are its ability to significantly decrease the incidence of herpes zoster and consequently of post-herpetic neuralgia compared with placebo. The most common side effects are pain at the injection site, myalgia, fatigue and headache. Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older.