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Gilead (GILD) Gets FDA Nod for Veklury for Hepatic Impairment
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Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has approved a label expansion of its anti-viral drug, Veklury (remdesivir).
Veklury is now approved in the United States without any dose adjustments for the treatment of COVID-19 in patients with mild, moderate or severe hepatic impairment.
While the efficacy of the treatment in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, the pharmacokinetics of Veklury has not been previously evaluated in patients with hepatic impairment.
The FDA’s approval is based on results from a phase I study in people with hepatic impairment (GS-US-540-9014), wherein no new safety signals were observed. Gilead conducted this multicenter, open-label, single-dose study to evaluate the pharmacokinetics and safety of Veklury and its metabolites in participants with normal hepatic function and moderate or severe hepatic impairment.
The latest FDA approval in this patient population supports the safety profile of Veklury as the first and only approved anti-viral COVID-19 treatment that can be used across all stages of liver disease.
However, the label still recommends initial hepatic laboratory testing in all patients before initiating treatment with Veklury and during treatment as clinically appropriate and that discontinuation be considered if alanine transaminase (ALT) levels increase 10 times the upper limit of normal or if ALT elevation is accompanied by signs or symptoms of liver inflammation.
These patients are vulnerable to COVID-19 and are at increased risk of morbidity and mortality.
Earlier, the FDA and the European Commission extended Veklury’s label to treat COVID-19 in people with severe renal impairment, including those on dialysis.
Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients who are hospitalized or have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Shares of Gilead have lost 11.1% so far this year compared with the industry’s decline of 13.4%.
Image Source: Zacks Investment Research
The outbreak of COVID-19 in 2020 and the need for urgent treatment for those infected significantly boosted Veklury sales in 2021. However, sales are on a declining trajectory, thereafter, with the advent of vaccines and the easing of the pandemic.
Veklury sales plunged 58% year over year to $829 million in the first half of 2023, primarily driven by lower rates of COVID-19-related hospitalizations. This decline also impacted year-over-year revenue growth. Concurrently, Gilead stated that it now expects Veklury sales of approximately $1.7 billion in 2023 compared with the previous estimate of approximately $2.0 billion.
Gilead is currently looking to boost its portfolio with the development of innovative HIV treatments and oncology drugs.
HIV treatment, Biktarvy, remains the leading treatment choice for those seeking to switch to a new regimen in the United States as well as for those switching therapies. Earlier, the FDA approved Sunlenca (lenacapavir), in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug-resistant HIV-1 infection.
The oncology business also continues to perform well and the label expansion of Trodelvy will further boost the franchise.
However, competition from the likes of GSK plc (GSK - Free Report) is stiff in the HIV space. Strong patient demand for the oral two-drug regimen (Oral 2DR- Dovato, Juluca) and long-acting medicines (Cabenuv and Apretude) were responsible for the growth of GSK’s HIV franchise in the second quarter of 2023.
The loss per share estimate for SPRO for 2023 has narrowed by 49 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 27 cents to 24 cents for 2023 in the past 30 days. Dynavax has risen 39.6% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.
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Gilead (GILD) Gets FDA Nod for Veklury for Hepatic Impairment
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has approved a label expansion of its anti-viral drug, Veklury (remdesivir).
Veklury is now approved in the United States without any dose adjustments for the treatment of COVID-19 in patients with mild, moderate or severe hepatic impairment.
While the efficacy of the treatment in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, the pharmacokinetics of Veklury has not been previously evaluated in patients with hepatic impairment.
The FDA’s approval is based on results from a phase I study in people with hepatic impairment (GS-US-540-9014), wherein no new safety signals were observed. Gilead conducted this multicenter, open-label, single-dose study to evaluate the pharmacokinetics and safety of Veklury and its metabolites in participants with normal hepatic function and moderate or severe hepatic impairment.
The latest FDA approval in this patient population supports the safety profile of Veklury as the first and only approved anti-viral COVID-19 treatment that can be used across all stages of liver disease.
However, the label still recommends initial hepatic laboratory testing in all patients before initiating treatment with Veklury and during treatment as clinically appropriate and that discontinuation be considered if alanine transaminase (ALT) levels increase 10 times the upper limit of normal or if ALT elevation is accompanied by signs or symptoms of liver inflammation.
These patients are vulnerable to COVID-19 and are at increased risk of morbidity and mortality.
Earlier, the FDA and the European Commission extended Veklury’s label to treat COVID-19 in people with severe renal impairment, including those on dialysis.
Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients who are hospitalized or have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Shares of Gilead have lost 11.1% so far this year compared with the industry’s decline of 13.4%.
Image Source: Zacks Investment Research
The outbreak of COVID-19 in 2020 and the need for urgent treatment for those infected significantly boosted Veklury sales in 2021. However, sales are on a declining trajectory, thereafter, with the advent of vaccines and the easing of the pandemic.
Veklury sales plunged 58% year over year to $829 million in the first half of 2023, primarily driven by lower rates of COVID-19-related hospitalizations. This decline also impacted year-over-year revenue growth. Concurrently, Gilead stated that it now expects Veklury sales of approximately $1.7 billion in 2023 compared with the previous estimate of approximately $2.0 billion.
Gilead is currently looking to boost its portfolio with the development of innovative HIV treatments and oncology drugs.
HIV treatment, Biktarvy, remains the leading treatment choice for those seeking to switch to a new regimen in the United States as well as for those switching therapies. Earlier, the FDA approved Sunlenca (lenacapavir), in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug-resistant HIV-1 infection.
The oncology business also continues to perform well and the label expansion of Trodelvy will further boost the franchise.
However, competition from the likes of GSK plc (GSK - Free Report) is stiff in the HIV space. Strong patient demand for the oral two-drug regimen (Oral 2DR- Dovato, Juluca) and long-acting medicines (Cabenuv and Apretude) were responsible for the growth of GSK’s HIV franchise in the second quarter of 2023.
Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Spero Therapeutics (SPRO - Free Report) and Dynavax Technologies (DVAX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The loss per share estimate for SPRO for 2023 has narrowed by 49 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 27 cents to 24 cents for 2023 in the past 30 days. Dynavax has risen 39.6% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.