The FDA issued a Complete Response Letter for its combination treatment of cabotegravir and rilpivirine.
GlaxoSmithKline received a bit of coal in its stocking from the U.S. Food and Drug Administration (FDA). The regulatory agency rejected an HIV treatment developed by its subsidiary, ViiV Healthcare. The FDA issued a Complete Response Letter for its combination treatment of cabotegravir and rilpivirine.
ViiV, which is also partly owned by Pfizer and Shionogi Limited, announced Saturday that the FDA rejected its New Drug Application for the combination of cabotegravir and rilpivirine as a long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults due to “Chemistry Manufacturing and Controls.” GSK stressed that the regulatory agency did not raise concerns over the safety issues associated with manufacturing and there is no change to the safety profile of the products used in clinical trials to date.
ViiV said it will work closely with the FDA to determine the appropriate next steps for this New Drug Application. Cabotegravir is an integrase strand transfer inhibitor developed by ViiV Healthcare and rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland UC.
In August, ViiV announced that the combination of cabotegravir and rilpivirine administered every eight weeks was non-inferior in treating the disease as the same two drugs administered monthly. The data was exciting for the HIV community as it showed the drug would not have to be administered as often as others, which should increase drug compliance.
“This is further progress in our efforts to reduce the number of medicines a person living with HIV must take while also reducing the frequency of treatments. The ATLAS-2M study results mean that people living with HIV could maintain viral suppression with six total treatments per year, instead of a daily oral treatment 365 times per year. Approval of this regimen would mark a significant change in the HIV treatment paradigm,” Kimberly Smith, head of R&D at ViiV said in a statement at the time the news was announced.
While the company saw a setback with its combination of cabotegravir and rilpivirine, earlier this month it submitted a New Drug Application for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection. Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations. This submission is supported by the data from the pivotal Phase III BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV.
ViiV Chief Executive Officer Deborah Waterhouse said that fostemsavir could become an important treatment option for HIV patients who have not been able to suppress the virus with other medications and have few treatment options available.
In keeping with our mission of leaving no person with HIV behind, we have overcome many barriers to bring this important new medicine to people living with HIV, including investing in what is a very complex manufacturing process. We look forward to working with the FDA to make fostemsavir available to the people in the U.S. who need it,” she said in a statement.
