Glaxo Seeks FDA Approval for Experimental Shingles VaccineBy
Shingrix could generate sales of 638 million pounds by 2020
Merck’s Zostavax already FDA approved for adults 50 and over
GlaxoSmithKline Plc said it sought regulatory approval in the U.S. for its experimental shingles vaccine which, if successful, could generate more than $700 million in annual sales for the British drugmaker and compete with Merck & Co.’s Zostavax
The filing for Shingrix, which helps prevent herpes zoster and its complications, was submitted to the Food and Drug Administration after late-stage clinical tests in more than 37,000 people, Glaxo said in a statement on Monday. The vaccine could generate 638 million pounds ($779 million) in sales by 2020, according to the average of eight analyst estimates compiled by Bloomberg.
Shingles is caused by the varicella zoster virus -- the same member of the herpes family that causes chickenpox. After an attack of chickenpox, the virus lies dormant in the body and can reappear, usually in the elderly or in people with compromised immune systems, in the form of painful shingles. A study published last month in the New England Journal of Medicine found that Glaxo’s vaccine remained effective for at least four years, unlike Merck’s Zostavax, which loses efficacy over time.
Glaxo is seeking approval for the vaccine to be administered to people aged 50 years or over.
Zostavax is approved for use in the U.S. in people aged 50 and over, based on a large study that found the vaccine reduced the risk of shingles by about 70 percent. In people over 60, the vaccine’s efficacy wanes within five years of vaccination, according to the U.S. Centers for Disease Control and Prevention.
People who received the two-dose Shingrix, meanwhile, had an 88 percent lower risk of developing shingles in the fourth year after vaccination, compared with a 91 percent reduction over the entire period of the late-stage trial, according to results published in the New England Journal of Medicine on Sept. 14.
Glaxo, the U.K.’s biggest drugmaker, plans to seek regulatory approval in the EU and Canada this year, and in Japan in 2017. Shingrix is administered in two doses, with a two-to six-month interval between doses.
Because Shingrix is made of a protein from the surface of the varicella zoster virus, and not a live version of the virus, Glaxo is testing it in patients with blood cancers, HIV and transplant patients, to find out whether it can protect people with compromised immune systems against shingles. Generally live vaccines like Merck’s Zostavax are not used in immune-compromised patients.