(Adds comment on FDA CRL, details on Health Canada approval)
March 20 (Reuters) - GlaxoSmithKline’s HIV treatments division has received approval for its long-acting HIV injection from Canada’s healthcare regulator, in a major win for the British drugmaker after a U.S. rejection late last year.
GSK's ViiV Healthcare said on Friday that Health Canada had given the green light to Cabenuva, a monthly injection to suppress the virus that causes AIDS and is aimed as an alternative to daily pills. (bit.ly/3aatmo8)
In December, the U.S. Food and Drug Administration (FDA) had declined to approve the treatment and questioned its chemistry, manufacturing and controls process, but not its safety in a complete response letter (CRL).
A GSK spokesperson said on Friday the company was continuing to work with FDA to address the watchdog’s questions.
ViiV Healthcare, in which Pfizer and Shionogi have small stakes, said Health Canada had also approved Vocabria, an oral tablet to be given along with Cabenuva for a short time.
The Canadian approval is the first for the regimen and bolster GSK’s push to using fewer drugs in HIV treatments, as it looks to boost sales by offering patients a therapy with fewer potentially toxic side effects.
Currently, U.S. drugmaker Gilead dominates the HIV market with its fast-growing Biktarvy.
The Cabenuva injection contains two active ingredients - cabotegravir and Janssen’s rilpivirine - and has previously proven as effective as standard daily pills with three active ingredients when given monthly and also once every two months. (Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger in Frankfurt; Editing by Vinay Dwivedi)