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Gilead (GILD) Gets FDA Nod for Label Expansion of Epclusa

By Zacks Investment ResearchStock MarketsJun 11, 2021 01:57AM ET
Gilead (GILD) Gets FDA Nod for Label Expansion of Epclusa
By Zacks Investment Research   |  Jun 11, 2021 01:57AM ET
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Gilead Sciences (NASDAQ:GILD), Inc. GILD announced that the FDA has approved a label expansion of its hepatitis C virus (HCV) drug, Epclusa.

The drug has now been approved for treating children as young as 3 years of age, regardless of HCV genotype or liver disease severity. The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa in children aged 3 years and older is based on weight.

The new oral pellet formulation enables treatment in early childhood with pangenotypic, panfibrotic regimen.

The approval was based on data from a phase II, open-label clinical study that enrolled 41 children, aged 3 years to less than 6 years, to be treated with Epclusa for 12 weeks. At 12 weeks after treatment completion, Epclusa achieved a sustained virologic response (SVR12) or cure rate of 83% (34/41) among all patients, 88% (28/32) in children with HCV genotype 1, 50% (3/6) in children with HCV genotype 2, and 100% in children with HCV genotype 3 (2/2) and HCV genotype 4 (1/1) each. Of the seven patients who did not achieve a cure, all discontinued treatment within one to 20 days of starting treatment.

Gilead’s stock has gained 18.1% this year compared with the industry's gain of 1.9%.

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The company’s first-quarter results were disappointing as the HIV business was adversely impacted by the ongoing pandemic. Competition is stiff as well from the likes of GlaxoSmithKline (NYSE:GSK) GSK.

The COVID-19 pandemic is expected to adversely impact HCV treatment initiations and HIV new starts and switches. Gilead expects a more gradual recovery in COVID-related dynamics, starting the second quarter of 2021.

The company is looking to diversify its revenue base as the virology business faces challenges. Gilead recently expanded its collaboration with Novo Nordisk (NYSE:NVO) NVO in non-alcoholic steatohepatitis (“NASH”) with plans to launch a new phase IIb study for a triple combination regimen in NASH patients with cirrhosis.

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector includes Repligen (NASDAQ:RGEN) Corp. RGEN, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 90 days.

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Gilead (GILD) Gets FDA Nod for Label Expansion of Epclusa

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Gilead (GILD) Gets FDA Nod for Label Expansion of Epclusa

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