FDA approves fixed dose raltegravir/3TC formulation: Merck holds back from marketing in US
24 March 2015. Related: Antiretrovirals.
Simon Collins, HIV i-Base
On 6 February 2015, the FDA approved a dual formulation of 300 mg raltegravir with 150 mg lamivudine (3TC). [1]
The indication is for use in combination with other antiretroviral drugs to treat HIV-1 in adults or children older than six years. Approval was based on pharmacokinetic equivalence in an open-label, single dose, randomised, two-period, crossover study in HIV negative people (n=108).
The new formulation uses a lower dose of raltegravir that has better bioavailability compared to the current 400 mg twice-daily formulation.
Raltegravir is an integrase inhibitor and 3TC is an NRTI that is now off-patent.
The joint formulation is manufactured by Merck and has the brand name Dutrebis.
Merck does not plan to make this new formulation commercially available immediately post-approval.
Comment
Merck announced submission of this formulation in June 2014. [2]
Approval in the EU is expected within two months, following a positive recommendation by the Committee for Human Medicinal Products (CHMP) on 22 January 2015. In Europe, a pharmacovigilance plan will be implemented as part of the marketing authorisation. [3]
Although Merck are not planning to market this in the US, the company are still looking at whether there may be a greater role for the formulation in the UK and Europe.
References:
- FDA listserve. Dutrebis approved, though not commercially marketed in US at this time. (9 February 2015).
http://content.govdelivery.com/accounts/USFDA/bulletins/eff796 - Merck press statement. FDA accepts Merck’s NDA for fixed-dose combination of raltegravir plus lamivudine. (24 June 2014).
http://www.mercknewsroom.com/news-release/research-and-development-news/fda-accepts-mercks-nda-fixed-dose-combination-raltegravir
http://www.mercknewsroom.com/news-releases - Committee for Medicinal Products for Human Use (CHMP) Summary of opinion (initial authorisation): Dutrebis lamivudine/raltegravir. EMA/CHMP/38006/2015 CHMP. (22 January 2015).
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003823/WC500180895.pdf (PDF)