By Millie Turner
British pharmaceutical giant GlaxoSmithKline (GSK) grew a step closer to securing its first drug approval since the split from its consumer health unit Haleon in July, but concerns over its share price remain.
The US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) have agreed that the benefit of GSK’s Daprodustat, used to treat anaemia of chronic kidney disease, “outweighs the risks” for adult dialysis patients with a 13 to 3 vote, the company announced on Thursday.
However, in adult non-dialysis patients with anaemia of chronic kidney disease, the Committee did not support that the benefit of treatment with Daprodustat outweighs the risks with a 5 to 11 vote.
Chronic kidney disease affects around 700 million patients worldwide, with an estimated one in seven patients also developing anaemia.
“While Daprodustat looks set to be first-in-class in the field, the mixed yes/no adcom vote will likely limit an FDA label to dialysis patients only and the split decision won’t fill prescribing physicians with confidence, given wider safety concerns across the drug class,” Edward Thomason, senior equity research analyst at brokerage Liberum, told City A.M.
“This setback, coupled with the recent decision to discontinue its leading T-cell therapy and otilimab’s phase III failure in rheumatoid arthritis, continues to show poor R&D execution.”
GSK’s share price is down more than 25 per cent in the year to date. And while the London-listed company could be on the brink of a milestone, it is not expected to be enough to ease all investor concerns.
The split from Haleon was expected to allow GSK to streamline its R&D efforts.
“Sadly, GSK’s R&D execution continues to be poor, and I don’t think Daprodustat’s likely approval will meaningfully improve investor confidence,” added Thomason.
“The one bright spot has been in infectious diseases, which the market was slow to price in, although recent setbacks might stall this share price rebound.”
The potential approval is also around a “year in the making”, Soo Romanoff, a managing director at investment research group Edison, told City A.M.
“The demerger has provided the company with a degree of flexibility in how it deploys capital in the pipeline but the upcoming potential approval is year in the making.
“Important for the future will be if GSK can continue to progress assets through the pipeline.”
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