Fostemsavir submitted to US FDA for multidrug resistant HIV

13 December 2019. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 5 December 2019, ViiV Healthcare announced that the company had submitted a new drug application for fostemsavir to the US FDA. [1]

Fostemsavir is a gp120 attachment inhibitor, the first drug in this new class, that was developed as a treatment for people with multi-drug resistance to other HIV drugs.

The submission is based on 96-week results from the phase 3 BRIGHTE study. [2, 3]

Submission to the EMA for access in the EU is expected in early 2020.

comment

A limited named patient access programme is available, including in the UK, for people who are urgently need access to fostemsavir before it will be approved.

For details, doctors should directly contact ViiV Healthcare.

References

1. ViiV Healthcare press release. ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available. (5 December 2019).
   https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-submits-new-drug-application-to-the-fda-for-fostemsavir-an-investigational-first-in-class-attachment-inhibitor-for-the-treatment-of-hiv-in-adults
2. Collins S. Fostemsavir: 96-week follow-up in people with multi-drug resistance. HTB 24 July 2019.
   https://i-base.info/htb/36390
3. Lataillade M et al Week 96 safety and efficacy of the novel HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced participants infected with multi-drug resistant HIV-1 (BRIGHTE study). 10th IAS Conference on HIV Science (IAS 2019), 21-24 July 2019, Mexico City. Oral abstract MOAB0102.
   http://programme.ias2019.org/Abstract/Abstract/3372