BMS's HIV drug gets FDA breakthrough status

Bristol-Myers Squibb (BMS) receives the US FDA breakthrough therapy designation for investigational HIV-1 attachment inhibitor for heavily treatment-experienced patients


The attachment inhibitor is designed to work differently than entry inhibitors

Bristol-Myers Squibb (BMS) has announced that the US Food and Drug Administration (US FDA) has granted Breakthrough Therapy Designation to the investigational compound BMS-663068, when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor.

The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors' activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus' initial interaction with immune cells entirely, and thus blocks its entry into the cell.

The designation is based on data from the Phase IIb clinical study comparing BMS-663068 to a boosted protease inhibitor (Reyataz (atazanavir sulfate) and ritonavir) in treatment-experienced patients, with a treatment backbone across all arms of raltegravir, in addition to tenofovir disoproxil fumarate. Week 48 results from the Phase IIb trial were presented earlier this year at the 22nd Conference on Retroviruses and Opportunistic Infections (CROI) and supported the continued clinical development of the attachment inhibitor.

A Phase III trial in heavily treatment-experienced patients (defined as individuals who can no longer formulate a viable three-drug treatment regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications) began in February 2015 and is ongoing.

"We are now 30-plus years into the AIDS epidemic, and there is an ever-increasing number of long-term survivors of the condition, many of whom are facing issues of drug resistance and are in need of new treatment options," said Mr Douglas Manion, head of specialty development, Bristol-Myers Squibb. He added, "The Breakthrough Designation recognizes the unmet need for novel therapies for this growing group of heavily treatment-experienced patients, and is evidence of Bristol-Myers Squibb's continued focus on meeting that need."


Previous 1 Next
4 Comment Comment 1 - 2 of 2

Bayport 29 September 2016 at 02:49 PM

We Offer Private, Commercial and Personal funds with very Minimal annual Interest Rates as Low as 3% within a 3months to 20years repayment duration period to any part of the world. We give out loans within the range of $5,000 to $10,000,000 USD. Our loans are well insured for maximum security is our priority,contact us to day via Email; for more details.



Your name(Required) 23 July 2015 at 05:15 PM

Good day My Name is Mike mougar i am here to share a great testimony of my life i was cure from HIV by a Doctor Name DR CUBA i have been HIV for 5 year i saw doctor Email on the internet so i contact him and i explain to him i follow up the instruction behold 6 days later after taking the cure i went for a HIV text to my surprise it was Negative my family doctor was surprise my husband who abandon me was surprise my brother if you no that you are positive please i will advise you to contact him now and see for your self his Email is why is website is......[] and also you can contact him on whatsapp +2347038965900


Leave a Reply Sign in

Notify me of follow-up comments via e-mail address

Post Comment

Survey Box

National Health Policy

Is National Health Policy 2017 helpful for patients?

Send this article by email