FDA approves fostemsavir (Rukobia) for multidrug resistant HIV in the US

22 July 2020. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 2 July 2020, the US FDA approved fostemsavir as an HIV treatment for people with extensive drug resistance and few choices for antiretroviral treatment (ART). [1, 2]

Fostemsavir is a gp120 attachment inhibitor, the first drug in this new class, that works at an early stage of the HIV lifecycle to block the virus from infecting CD4 cells.

The indication also covers people who are failing their current ART due to resistance, intolerance or safety considerations.

Approval was primarily based on results from the international phase 3 BRIGHTE study, which has reported 96-week follow-up, but longer term results are available from some participants out to week 192. [3, 4]

Fostemsavir (previously BMS-663068) has had a long development history, and was acquired by ViiV Healthcare from Bristol-Myers Squibb with other investigational compounds in 2015.

Fostemsavir is dosed at 600 mg twice-daily.

Potential drug-drug interactions are possible with strong cytochrome P450 (CYP)3A inducers, would significantly reduce temsavir (the active moiety of fostemsavir) plasma concentrations. These drugs include, but are not limited:

• Androgen receptor inhibitor: enzalutamide
• Anticonvulsants: carbamazepine, phenytoin
• Antimycobacterial: rifampin
• Antineoplastic: mitotane
• Herbal product: St John’s wort (Hypericum perforatum)

Fostemsavir is marketed by ViiV Healthcare under the trade name Rukobia.

For more details please see the full prescribing information. [5]

COMMENT

Although the pool of people on failing ART with multiple drug resistance is luckily small, fostemsavir In combination with other active drugs, is likely to be a life-saving option.

Fostemsavir was submitted to the EMA for approval in the EU in January 2020, with a decision expected shortly.

A limited named patient access programme is available, including in the UK, for people who urgently need access to fostemsavir. For details, doctors should directly contact ViiV Healthcare.

References

1. FDA press release. FDA approves new HIV treatment for patients with limited treatment options (2 July 2020).
   https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-treatment-patients-limited-treatment-options
2. ViiV press release. ViiV Healthcare announces US FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults with few treatment options available. (2 July 2020).
   https://viivhealthcare.com/en-gb/media
3. Collins S. Fostemsavir: 96-week follow-up in people with multi-drug resistance. HTB (24 July 2019).
   https://i-base.info/htb/36390
4. Thompson M et al. Long-term safety & efficacy of fostemsavir in treatment-experienced HIV participants. CROI 2019, 4 – 7 March, Seattle. Poster abstract 483.
   https://www.croiconference.org/abstract/long-term-safety-efficacy-fostemsavir-treatment-experienced-hiv-participants
5. Ruktobia US Prescribing Information. (Still to be posted).
   https://medlineplus.gov/druginfo/drug_Ra.html (FDA website)
   https://viivhealthcare.com/en-us/our-medicines (ViiV website)

This report was first published on 2 July 2020.