GlaxoSmithKline plc GSK recently announced that an FDA advisory panel has unanimously voted recommending approval for its shingles vaccine candidate, Shingrix, in older patients.
Glaxo said the FDA’s Vaccines and Related Biological Products Advisory Committee were impressed by the efficacy/safety data from Shingrix studies, which evaluated the candidate for the prevention of herpes zoster (shingles) in adults aged between 50 years and more. In this regard, although the FDA is not bound to follow the Committee’s opinion but it usually does.
So far this year, Glaxo’ share price has increased 4.1%, comparing unfavorably with a gain of 16% recorded by the industry it belongs to.
Notably, the biologics license application (BLA) for Shingles was filed with the FDA in October, 2016. Regulatory applications are currently under review in the EU, Canada and Japan as well.
The regulatory submission was based on data from a clinical trial program comprising two phase III studies — ZOE-50 and ZOE-70 — that evaluated the safety, efficacy and immunogenicity of the candidate in more than 37,000 individuals. The results showed that in addition to reducing the incidence of shingles, the candidate was able to reduce the overall incidence of postherpetic neuralgia, which is a nerve pain due to the damage caused by the varicella zoster virus.
Glaxo expects approval of Shingrix in the United States and Europe in the fourth quarter of 2017.
In fact, Shingles is a common but potentially serious condition in which the patients develop a painful itchy rash. Glaxo estimates that more than one in three people over 50 are likely to have shingles in their lifetime, which shows the disease has significant unmet need.
Glaxo expects Shingles, if approved, to be a key contributor to its top line from the next year. Additionally, the company anticipates new pharmaceutical and vaccine products including Shingrix to deliver sales of £6 billion per annum by 2018.
Glaxo carries a Zacks Rank #3 (Hold).
Stocks to Consider
Better-ranked biotech stocks include Alexion Pharmaceuticals, Inc. ALXN, Regeneron Pharmaceuticals, Inc. REGN and Ligand Pharmaceuticals Incorporated LGND, each sporting a Zacks Rank #1 (Strong Buy). You can seethe complete list of today’s Zacks #1 Rank stocks here.
Shares of Alexion have gained 19.8% year to date. The Zacks Consensus Estimate for 2017 and 2018 have climbed 5.5% and 6%, respectively, over the past 60 days.
Regeneron’s shares have rallied 19.2% this year so far. Its estimates have moved up 16.8% for 2017 while that for 2018 have climbed 8.2% over the past 60 days.
Shares of Ligand have surged 35.8% so far this year.
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GlaxoSmithKline PLC (GSK) : Free Stock Analysis Report
Alexion Pharmaceuticals, Inc. (ALXN) : Free Stock Analysis Report
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