EU recommendations for Gilead, Ariad and Baxter drugs

Gilead Sciences, Ariad Pharma and Baxter have all received backing from the European Medicines Agency (EMA) to market new treatments.

The regulator released the latest round of opinions from its Committee for Medicinal Products for Human Use (CHMP), which recommend approvals for Baxter’s HyQvia for immunodeficiency disorders; Ariad’s Iclusig for leukaemia; and Gilead’s combination HIV medicine Stribild.

Baxter’s HyQvia is a human normal immunoglobulin that is recommended as a solution for subcutaneous injection to replace immunoglobulin in adults with primary immunodeficiency syndromes, including common variable immunodeficiency.

It is also recommended in patients with myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia – a reduction in the level of gamma globulins – and recurrent infections.

If approved by the European Commission, patients with these conditions in Europe will be able to administer the therapy at home once every three to four weeks

According to Ludwig Hantson, president of Baxter’s bioscience business, this could result in “potentially lower systemic adverse reactions compared to intravenous treatments”.

Iclusig approved to treat leukaemia The CHMP also gave a positive opinion to Ariad Pharma for the use of Iclusig (ponatinib) to treat two types of leukaemia in patients resistant to current drugs.

Specifically, the recommendation covers the use of Iclusig in patients with chronic myeloid leukaemia (CML) who cannot take or are resistant to Bristol-Myers Squibb’s Sprycel (dasatinib) or Novartis’ Tasigna (nilotinib) and for whom subsequent treatment with Novartis’ Glivec (imatinib) is not appropriate.

It also covers patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to or cannot take Sprycel, and for whom Glivec isn’t a follow-on option.

Patients with either condition who have the T315I mutation should also have access to Iclusig, according to the CHMP.

The recommendation comes after an accelerated assessment for Iclusig, which the EMA grants to medicines in areas of high unmet medical need or that are expected to have major impact on medical practice.

In doing so it can potentially cut months off an approval timeline, and has helped Ariad close the gap on Pfizer, which received CHMP backing earlier this year for the use of bosutinib to treat patients with CML who are resistance to current treatments.

In the US, Iclusig received FDA approval in December 2012, while Pfizer’s bosutinib was approved under the brand name Bosulif in September 2012.

Europe backs Gilead’s combination HIV therapy There was also good news for Gilead, which received a recommendation for its once-daily combination HIV therapy Stribild.

The drug combines elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil – each working in different ways to treat the virus – and offers HIV patients in Europe a less complicated treatment option than taking multiple pills a day.

The EMA recommendation covers human the use of Stribild in adult patients with the HIV 1 variant who are antiretroviral treatment-naïve or are infected with HIV 1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.

Gilead’s application was supported by data that demonstrated Stribild maintained high antiviral efficacy through 96 weeks of treatment and was not inferior to Gilead’s other once-daily combination pill Atripla, as well as to a regimen containing ritonavir-boosted atazanavir plus Truvada.

Stribild is already available in the US, Canada, South Korea and Australia, and Gilead has granted access to manufactures in India and the Medicines Patent Pool to distribute generic versions of the drug in 100 developing nations.

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