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ViiV HEALTHCARE SUBMITS NEW DRUG APPLICATION TO US FDA FOR THE FIRST MONTHLY, INJECTABLE, TWO-DRUG REGIMEN OF CABOTEGRAVIR AND RILPIVIRINE FOR TREATMENT OF HIV
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This is brief press release, full press release at
https://viivhealthcare.com/en-gb/media/press-releases/2019/april/viiv-healthcare-submits-new-drug-application-to-us-fda-for-the-first-monthly-injectable-two-drug-regimen-of-cabotegravir-and-rilpivirine-for-treatment-of-hiv/
If approved, cabotegravir and rilpivirine would be the first-ever long-acting, injectable treatment regimen for adults living with HIV
London, 29 April 2019 - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the investigational, monthly, injectable, two-drug regimen of ViiV Healthcare's cabotegravir and Janssen's rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
The submission is based on the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies that included more than 1,100 patients from 16 countries and demonstrated the combination of cabotegravir and rilpivirine, injected monthly, was as effective as a standard of care, daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period. These results were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections.
Deborah Waterhouse, CEO of ViiV Healthcare, said: "The long-acting, once-monthly, injectable regimen of cabotegravir and rilpivirine has the potential to give people living with HIV one month between doses with similar safety and efficacy as today's standard of care - an oral three-drug regimen that has to be taken every day. ViiV Healthcare is proud to be at the forefront of this innovation in HIV treatment and we look forward to working with the FDA to provide people living with HIV in the US this novel option."
John C. Pottage, Jr., M.D., Chief Scientific and Medical Officer of ViiV Healthcare, commented: "Our focus on developing innovative new HIV treatments, including long-acting injectable therapies, supports our goal of giving people living with HIV more options for managing the virus. The ATLAS and FLAIR data support the efficacy and safety of this investigational two-drug regimen, and the fact that more than 85 percent of study participants said they preferred it to their prior, daily oral therapy suggests we are delivering a welcome option. If approved, people receiving the monthly injectable regimen of cabotegravir and rilpivirine will reduce the number of days they have to take treatment from 365 to 12 per year."
ViiV Healthcare and Janssen plan to submit regulatory applications for the two-drug regimen of cabotegravir and rilpivirine to the European Medicines Agency, Health Canada and other global agencies in the coming months.
As part of the regulatory submission package to the FDA, ViiV Healthcare submitted a second NDA for an oral tablet formulation of cabotegravir that would be taken as an oral lead-in with an already-approved, once-daily, oral tablet formulation of rilpivirine (marketed by Janssen as EDURANT®).
The ATLAS and FLAIR studies are part of ViiV Healthcare's innovative clinical trial programme for two-drug regimens.
Notes to editors: About ATLAS and FLAIR
ATLAS (NCT02951052) is a phase III, open-label, active-controlled, multicentre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of long-acting, injectable cabotegravir and rilpivirine dosed every four weeks compared to continuation of current oral anti-retroviral therapy (ART) of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI) among virally suppressed individuals. The primary endpoint for ATLAS is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population). Subjects were required to be virally suppressed for six months or greater, on first or second regimen, with no prior failure.
FLAIR (NCT02938520) is a phase III, randomised, open-label, multicentre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of intramuscular, long-acting, injectable cabotegravir and rilpivirine in virologically suppressed adults living with HIV, following 20 weeks of induction therapy with Triumeq (abacavir, dolutegravir, and lamivudine tablets). The primary endpoint for FLAIR is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population).
About cabotegravir
Cabotegravir is an investigational integrase inhibitor (INI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV. It is being evaluated as a long-acting formulation for intramuscular injection and also as a once-daily oral tablet for use as a lead-in, to establish the tolerability of cabotegravir prior to long-acting injection.
About rilpivirine
EDURANT® (rilpivirine) is a once daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of human immunodeficiency virus (HIV-1) infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35-kg with a viral load ≤ 100,000 HIV RNA copies/mL. Long-acting injectable rilpivirine is not approved by regulatory authorities anywhere in the world.
Rilpivirine was developed by Janssen Sciences Ireland UC, one of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Rilpivirine is approved in the US and EU as EDURANT® as a 25mg tablet taken once-a-day and is always taken with a meal. The most common side effects of EDURANT include: depression, headache, trouble sleeping (insomnia) and rash.
Important Safety Information (ISI) for EDURANT® (Rilpivirine)
Note: this is taken from the US label and local variations apply. Please refer to applicable local labelling.
About EDURANT® (Rilpivirine)
• EDURANT® (rilpivirine) is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people 12 years of age and older and who weigh at least 77 lbs (35 kg):
- Have never taken HIV medicines before, and
- Have an amount of HIV in their blood (called "viral load") that is no more than 100,000 copies/mL
• EDURANT® is not recommended for patients less than 12 years of age or who weigh less than 77 lbs (35 kg)
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