ViiV gets CRL from FDA for rilpivirine and cabotegravir to treat HIV

HIV AIDS cases have been prevailing and increasingly growing across the world. Currently, about 37.9 million people are suffering from HIV globally. Several global pharmaceutical firms are increasingly working and investing heavily in R&D to find new therapies to treat people suffering from HIV. Additionally, several companies are also actively spreading awareness about this disease.    

ViiV Healthcare, a renowned pharmaceutical company working towards finding new treatments for HIV, reportedly announced that it received a CRL (complete response letter) from the US FDA (Food and Drug Administration). The company received CLR for its application for rilpivirine and cabotegravir long-acting regimen. These regimens developed by the company would be used to treat HIV-1 infection for virologically suppressed adults.  

The factors mentioned in the CRL correlate to CMC (Chemistry Manufacturing and Controls). No safety issues have been reported related to CMC. Additionally, no change is seen in the safety profile of the products that are utilized in clinical studies to date. ViiV Healthcare would closely work alongside the FDA to understand the next steps that are suitable for the New Drug Application. 

Cabotegravir is an integrase strand transfer inhibitor created by ViiV Healthcare while rilpivirine, created by Janssen Sciences Ireland UC, is a non-nucleoside reverse transcriptase inhibitor. The rilpivirine and cabotegravir long-acting regimen is still an investigational product. In fact, it has not been approved anywhere in the world.

The company submitted the application for rilpivirine and cabotegravir for testing to FDA back in April. Recently, the company also marked the submission of DTG (dolutegravir), which If approved by FDA and EMA, would become the first-ever dispersible formulation therapy made for children suffering from HIV.  

About ViiV:

ViiV Healthcare is a popular biopharmaceutical company established in November 2009 by Pfizer and GlaxoSmithKline. The company is an HIV specialist and is dedicated to providing advances in therapy and care for the people suffering from HIV. The company also works for people who are at risk of being infected from HIV. Shionogi linked with the company in October of 2012.

The primary aim of the company is to take a deeper interest in HIV/AIDS and its treatment, more than any other company and further gain a new insights that help find treatment for HIV. The company also aims to help communities affected with the disease.

 

Source credit: https://viivhealthcare.com/en-gb/media/press-releases/2019/december/complete-response-letter-from-us-fda/