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Glaxo (GSK) Gets FDA Nod for HIV Preventive Injectable Drug
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Glaxo’s (GSK - Free Report) HIV subsidiary, ViiV Healthcare announced that the FDA has granted approval to its long-acting injectable form of cabotegravir drug for the prevention of HIV infection, also called pre-exposure prophylaxis or PrEP.
The drug, to be marketed as Apretude in the United States, was approved for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV, including men who have sex with men as well as women and transgender women who have sex with men.
Apretude is the first and only long-acting injectable therapy approved for HIV prevention. It will reduce the daily administration of currently available oral pills for PrEP to as few as six injections a year.
So far this year, Glaxo’s shares have outperformed the industry, rising 23.8% compared with the industry’s 23% increase.
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The FDA’s decision came almost a month earlier than the expected action date of Jan 24, 2022. The NDA filing was based on results from two phase IIb/III studies, HPTN 083 and HPTN 084, which demonstrated that the cabotegravir regimen is superior compared to the daily oral regimen of emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) tablets in preventing HIV infection. Regulatory applications have also been filed in other countries.
Please note that an oral formulation of cabotegravir, with the trade name of Vocabria, is already approved in combination with J&J’s (JNJ - Free Report) Edurant (oral rilpivirine) for short-term treatment of HIV-1 infection.
A combination of long-acting injectable cabotegravir and J&J’s Edurant (rilpivirine) is approved as Cabenuva for the treatment of HIV-1 infection in virologically suppressed adults.
ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer (PFE - Free Report) .
After Pfizer and Glaxo established it in 2009, Japan’s Shionogi joined as shareholders in October 2012. Glaxo and Pfizer’s ViiV Healthcare focuses on advancing HIV care by exploring new treatment paradigms (two-drug regimens), modalities (long-acting injectables), and mechanisms of actions (including maturation inhibitors and broadly neutralizing antibodies).
A biotech stock with the same Zacks Rank as Glaxo is IVERIC bio .
IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 60 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 60 days. Shares of IVERIC bio have gained 126.5% in the year so far.
IVERIC bio’s earnings missed estimates in three of the last four quarters and surpassed expectations once, with the negative surprise being 5.6%, on average.
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Glaxo (GSK) Gets FDA Nod for HIV Preventive Injectable Drug
Glaxo’s (GSK - Free Report) HIV subsidiary, ViiV Healthcare announced that the FDA has granted approval to its long-acting injectable form of cabotegravir drug for the prevention of HIV infection, also called pre-exposure prophylaxis or PrEP.
The drug, to be marketed as Apretude in the United States, was approved for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV, including men who have sex with men as well as women and transgender women who have sex with men.
Apretude is the first and only long-acting injectable therapy approved for HIV prevention. It will reduce the daily administration of currently available oral pills for PrEP to as few as six injections a year.
So far this year, Glaxo’s shares have outperformed the industry, rising 23.8% compared with the industry’s 23% increase.
The FDA’s decision came almost a month earlier than the expected action date of Jan 24, 2022. The NDA filing was based on results from two phase IIb/III studies, HPTN 083 and HPTN 084, which demonstrated that the cabotegravir regimen is superior compared to the daily oral regimen of emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) tablets in preventing HIV infection. Regulatory applications have also been filed in other countries.
Please note that an oral formulation of cabotegravir, with the trade name of Vocabria, is already approved in combination with J&J’s (JNJ - Free Report) Edurant (oral rilpivirine) for short-term treatment of HIV-1 infection.
A combination of long-acting injectable cabotegravir and J&J’s Edurant (rilpivirine) is approved as Cabenuva for the treatment of HIV-1 infection in virologically suppressed adults.
ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer (PFE - Free Report) .
After Pfizer and Glaxo established it in 2009, Japan’s Shionogi joined as shareholders in October 2012. Glaxo and Pfizer’s ViiV Healthcare focuses on advancing HIV care by exploring new treatment paradigms (two-drug regimens), modalities (long-acting injectables), and mechanisms of actions (including maturation inhibitors and broadly neutralizing antibodies).
Glaxo currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Another Stock to Consider
A biotech stock with the same Zacks Rank as Glaxo is IVERIC bio .
IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 60 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 60 days. Shares of IVERIC bio have gained 126.5% in the year so far.
IVERIC bio’s earnings missed estimates in three of the last four quarters and surpassed expectations once, with the negative surprise being 5.6%, on average.