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ViiV’s two-drug HIV combo backed by CHMP

The committee also backs two biosimilar medicines

ViiV

ViiV Healthcare’s dual HIV therapy Juluca has been given a green light by the EMA’s Committee for Medicinal Products for Human Use (CHMP), setting up another front in its fierce rivalry with Gilead Sciences.

The advisory committee issued a positive opinion for Juluca - which combines ViiV’s integrase inhibitor Tivicay (dolutegravir) with a non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) developed by Johnson & Johnson’s Janssen unit - for adults with HIV infection.

ViiV’s chief executive Deborah Waterhouse said the approval recommendation “is an important milestone for people living with HIV in Europe [taking] us a step closer to offering the first, single-pill, two-drug regimen with the opportunity to reduce the number of drugs needed to treat HIV”.

At the moment most patients are treated with three-drug regimens, and ViiV says the two-drug regimens can reduce drug exposure and side effects, as well as improve adherence to therapy while maintaining the same level of efficacy.

The CHMP opinion follows approval of Juluca by the FDA last November, which was brought forward after ViiV’s majority shareholder GlaxoSmithKline used an FDA priority review voucher purchased for $130m.

Its main rival is expected to be Gilead’s new fixed-dose regimen Biktarvy, which combines integrase inhibitor bictegravir with the two ingredients in its fast-growing Descovy (emtricitabine/tenofovir alafenamide) product and was approved in the US last month. That approval has already sparked a lawsuit between the two rivals.

CHMP meeting round-up

Among other highlights the CHMP backed two biosimilar medicines - Amgen’s Kanjinti version of Roche’s Herceptin (trastuzumab) for the treatment of breast and gastric cancer and Sandoz’ Zessly, a biosimilar of J&J’s Remicade (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

It also gave its blessing to Clovis Oncology’s PARP inhibitor Rubraca (rucaparib) for the treatment of relapsed or progressive ovarian cancer in patients who have already been treated with two or more lines of platinum-based chemotherapy. Amgen also received a positive opinion on its bid to add cardiovascular outcomes data to the label of its cholesterol drug Repatha (evolocumab).

There was bad news for three other companies, with the CHMP issuing negative opinions for Portola’s Dexxience (betrixaban) for the prevention of venous thromboembolism, Radius International’s osteoporosis candidate Eladynos (abaloparatide) and confirming its earlier rejection of Pharma Mar’s Aplidin (plitidepsin) as a treatment for multiple myeloma.

Article by
Phil Taylor

26th March 2018

From: Regulatory

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