- Filing for FDA approval for Shingrix is on track for 2016
- Glaxo studying vaccine in HIV, cancer, transplant patients
GlaxoSmithKline Plc’s experimental shingles vaccine remained effective for at least four years in a study, unlike Merck & Co.’s competing Zostavax, which loses efficacy over time.
People who received the two-dose Shingrix vaccine 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 Wednesday in the New England Journal of Medicine.
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. The only currently approved vaccine to prevent shingles is Merck’s Zostavax, which had sales of $749 million last year.
In 2011, the U.S. Food and Drug Administration approved Zostavax for use in people aged 50 to 59 based on a large study that found the vaccine reduced the risk of shingles by about 70 percent. The agency had earlier approved its use for people 60 and older. In the older group, the vaccine’s efficacy wanes within five years of vaccination, according to the U.S. Centers for Disease Control and Prevention.
Glaxo is on track to apply for FDA approval for its shingles vaccine this year. The London-based drugmaker is also studying Shingrix, which is made of a protein from the surface of the virus, in people with compromised immune systems including those infected with HIV, and cancer and organ transplant patients. Initial results from those studies will be presented next year, said Thomas Breuer, chief medical officer at Glaxo’s vaccines division.
Shingrix could generate 638 million pounds ($842 million) in sales by 2020, according to the average of eight analyst estimates compiled by Bloomberg.