EU regulators back Gilead’s latest HIV combo pill

Gilead and Janssen’s possible HIV blockbuster, Odefsey (emtricitabine+rilpivirine+tenofovir alafenamide) has been given the green light by Europe’s top regulatory committee.

The CHMP backed Odefsey, the second drug recommended by the committee where Gilead replaced the disoproxil fumarate salt used in an older combination pill with alafenamide, allowing for a lower dose and a more favourable renal and bone safety profile.

Already approved by the US Food and Drug Administration in March, earlier this year Thomson Reuters forecast Odefsey, a daily tablet, will generate sales of almost $1.6 billion by 2020.

In February the CHMP backed Descovy (emtricitabine+tenofovir alafenamide), which has a similar action to Gilead’s older Truvada (emtricitabine+tenofovir disoproxil fumarate). Descovy’s sales are predicted to top $2 billion by 2020.

The CHMP recommended the drug for HIV patients aged 12 years and over without known mutations resistant to the active ingredients in the combination pill. The most common side effects are nausea, insomnia and dizziness.

Also recommended by the CHMP was GlaxoSmithKline’s (GSK) Umbipro (chlorhexidine) an antiseptic gel to prevent umbilical cord infections in newborn babies, for use in countries outside the European Union (EU).

GSK filed the drug under a procedure allowing the EMA to evaluate medicines for use in low-income countries outside the EU.

The EMA recommended AstraZeneca’s Zavicefta (ceftazidime+avibactam), an antibiotic for use against multi-drug resistant bacteria, Biogen and AbbVie’s Zinbryta (daclizumab) for relapsing multiple sclerosis, Bial’s Parkinson’s drug Ongentys (opicapone), and Aptalis Pharma’s Enzepi (pancreas powder) for exocrine pancreas insufficiency.

ITG’s EndolucinBeta (lutetium 177) was recommended as a radioactive label that could be added to a carrier molecule during molecular imaging.

The CHMP recommended expanding use of AbbVie and Janssen’s Imbruvica (ibrutinib) in adults with chronic lymphocytic leukaemia (CLL), allowing its use in newly-diagnosed and untreated adults. The existing label restricts its CLL use to second line, or in first line with certain mutations.

Imbruvica is also approved in mantle cell lymphoma and Waldenstrom’s macroglobulinemia indications.

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