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Gilead (GILD) Gets FDA Nod for Twice-Yearly HIV Treatment
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Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has approved lenacapavir in combination with other antiretroviral(s) (ARV) under the brand name Sunlenca for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug-resistant (MDR) HIV-1 infection.
The approval of this new, twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen will boost Gilead’s strong HIV franchise.
Sunlenca, a first-in-class, long-acting HIV capsid inhibitor, has a multi-stage mechanism of action distinguishable from other currently approved classes of antiviral agents. Most antivirals act on just one stage of viral replication, while Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes.
Sunlenca tablets are approved for oral loading during the initiation of treatment, prior to or at the time of the first long-acting lenacapavir injection, depending on the initiation option.
Sunlenca is the only HIV treatment option administered twice yearly and thus will have an advantage over other existing treatments due to its less frequent dosing requirements.
The FDA approval for Sunlenca is supported by data from the phase II/III CAPELLA study, which evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV-1 who are HTE. These patients had undergone previous treatment with a median of nine antiretroviral medications. 83% (n=30/36) of participants randomly allocated to receive lenacapavir in addition to an optimized background regimen achieved an undetectable viral load at week 52.
We remind investors that the FDA granted Breakthrough Therapy Designation to lenacapavir for the treatment of HIV-1 infection in HTE patients with multi-drug resistance in combination with other antiretroviral drugs.
In May 2022, the FDA lifted the clinical hold placed on Gilead’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP).
The hold was placed on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue. The FDA removed the clinical hold following the agency’s review of Gilead’s comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass.
We note that Sunlenca has already received approval from the European Union in August 2022. Additional regulatory filings and decisions by regulatory authorities are anticipated to continue in 2023.
Gilead’s HIV portfolio continues to maintain momentum for the company, driven by growth in demand for flagship HIV therapy Biktarvy. Descovy (FTC 200 mg/TAF 25 mg) sales have also boosted the top line. However, the loss of exclusivity for Truvada has hurt the company’s business.
Gilead has had a good run in 2022, as its shares have gained 17.5% in the year so far against the industry’s decline of 19.2%.
Image Source: Zacks Investment Research
However, competition is stiff in the HIV space from the likes of GSK plc (GSK - Free Report) and Johnson & Johnson (JNJ - Free Report) and hence the approval of new treatments holds the key.
In February 2022, Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved an expanded label for Cabenuva (rilpivirine and cabotegravir) to be administered every two months for the treatment of HIV-1 in virologically suppressed adults.
It was earlier approved in January 2021 as a once-monthly, complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed. The regimen was co-developed as part of a collaboration with ViiV Healthcare.
ViiV Healthcare was formed in 2009 by GSK and Pfizer. The partners were later joined by Shionogi in 2012.
Image: Bigstock
Gilead (GILD) Gets FDA Nod for Twice-Yearly HIV Treatment
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has approved lenacapavir in combination with other antiretroviral(s) (ARV) under the brand name Sunlenca for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug-resistant (MDR) HIV-1 infection.
The approval of this new, twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen will boost Gilead’s strong HIV franchise.
Sunlenca, a first-in-class, long-acting HIV capsid inhibitor, has a multi-stage mechanism of action distinguishable from other currently approved classes of antiviral agents. Most antivirals act on just one stage of viral replication, while Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes.
Gilead Sciences, Inc. Price and Consensus
Gilead Sciences, Inc. price-consensus-chart | Gilead Sciences, Inc. Quote
Sunlenca tablets are approved for oral loading during the initiation of treatment, prior to or at the time of the first long-acting lenacapavir injection, depending on the initiation option.
Sunlenca is the only HIV treatment option administered twice yearly and thus will have an advantage over other existing treatments due to its less frequent dosing requirements.
The FDA approval for Sunlenca is supported by data from the phase II/III CAPELLA study, which evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV-1 who are HTE. These patients had undergone previous treatment with a median of nine antiretroviral medications. 83% (n=30/36) of participants randomly allocated to receive lenacapavir in addition to an optimized background regimen achieved an undetectable viral load at week 52.
We remind investors that the FDA granted Breakthrough Therapy Designation to lenacapavir for the treatment of HIV-1 infection in HTE patients with multi-drug resistance in combination with other antiretroviral drugs.
In May 2022, the FDA lifted the clinical hold placed on Gilead’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP).
The hold was placed on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue. The FDA removed the clinical hold following the agency’s review of Gilead’s comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass.
We note that Sunlenca has already received approval from the European Union in August 2022. Additional regulatory filings and decisions by regulatory authorities are anticipated to continue in 2023.
Gilead’s HIV portfolio continues to maintain momentum for the company, driven by growth in demand for flagship HIV therapy Biktarvy. Descovy (FTC 200 mg/TAF 25 mg) sales have also boosted the top line. However, the loss of exclusivity for Truvada has hurt the company’s business.
Gilead has had a good run in 2022, as its shares have gained 17.5% in the year so far against the industry’s decline of 19.2%.
Image Source: Zacks Investment Research
However, competition is stiff in the HIV space from the likes of GSK plc (GSK - Free Report) and Johnson & Johnson (JNJ - Free Report) and hence the approval of new treatments holds the key.
In February 2022, Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved an expanded label for Cabenuva (rilpivirine and cabotegravir) to be administered every two months for the treatment of HIV-1 in virologically suppressed adults.
It was earlier approved in January 2021 as a once-monthly, complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed. The regimen was co-developed as part of a collaboration with ViiV Healthcare.
ViiV Healthcare was formed in 2009 by GSK and Pfizer. The partners were later joined by Shionogi in 2012.
Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.