Raltegravir + lamivudine

Unassigned

New Medicines

Dutrebis · HIV infection

Information

Dutrebis
New formulation
Merck Sharp & Dohme (MSD)
Merck Sharp & Dohme (MSD)

Development and Regulatory status

Licence withdrawn
Licence withdrawn
Launched
01. Mar 14: MAA filed in EU. [1]
02. Nov 14: EU filing is via centralised procedure [3].
03. Jun 14: New Drug Application accepted for standard review by the US FDA. [2]
04. Jan 15: EU positive opinion for use in combination with other anti-retroviral medicinal products for treatment of HIV 1 infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor ) classes [4].
05. Feb 15: Approved in US [7].
06. Mar 15: Launched in US [7].
07. Mar 15: Approved in EU [7].
08. May 16: Not yet been launched in UK [8].
09. Jan 17: MSD presently has no plans to launch Dutrebis in the UK [9].
10. Mar 18: MSD has no plans to launch in the UK; furthermore, the EU marketing authorisation has been withdrawn [10].

Category

HIV integrase inhibitor + NRTI
An estimated 83,000 people were living with HIV in 2008 in the UK; about 27% were unaware of their infection. In 2008, there were 7,298 new diagnoses of HIV.
HIV infection
Oral