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Two blood cancer drugs among CHMP recommendations

Five new drugs, including Janssen’s Imbruvica and Gilead’s Zydelig, backed for use in Europe
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Blood cancer drugs from Gilead and Janssen were among five new medicines recommended this month for use in the EU.

European Medicines Agency (EMA) scientific advisors backed approval for Janssen's Imbruvica and Gilead Sciences' Zydelig in patients with certain types of leukaemia and lymphoma.

The other major recommendation by the Committee for Medicinal Products for Human Use (CHMP) was for Xultophy, a combination of Novo Nordisk's insulin Tresiba and the GLP1 agonist Victoza.

The CHMP also granted positive opinions to Fresenius' generic version of the chemotherapy busulfan and to a biosimilar version of Amgen's Neupogen to be marketed by Accord.

Specifically, Imbruvica (ibrutinib) is recommended to treat patients with relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukaemia. The drug was approved in the US in a similar indication at the beginning of the year.

The drug is a Bruton's tyrosine kinase (BTK) inhibitor licensed by Janssen's parent company J&J from Pharmacyclics in 2011 in a deal involving an upfront payment of $150m plus potential development and commercial milestones of $825m.

Jane Griffiths, chairman for Janssen EMEA, said: “We've been closely collaborating with the CHMP on the Imbruvica submission and are delighted to receive the positive opinion earlier than expected. There is a high unmet medical need and recent clinical trials have demonstrated positive results for Imbruvica,”

The recommendation for Gilead's Zydelig (idelalisib) covers its use in the treatment of patients with chronic lymphocytic leukaemia and patients with refractory follicular lymphoma.

The EU decision came in the same week that the US FDA recommended the drug in three blood cancer indications.

CHMP backs Novo's diabetes combo

There was also good news for Novo, with the CHMP recommending Xultophy in the treatment of people with type 2 diabetes. The drug, which was previously known as IDegLira is a combination of Novo's insulin degludec Tresiba and Victoza (liraglutide), both of which are leading drivers in the growth of Novo's diabetes business.

The company has high expectations for the combination product, which has impressed in late-stage studies by demonstrating it can avoid common side effects of insulin treatment while still lowering blood sugar levels.

“We believe that Xultophy represents a new treatment paradigm with the potential to transform how type 2 diabetes is treated,” said Novo's chief science officer Mads Krogsgaard Thomsen.

Biosimilars and generics

The CHMP also recommended a new biosimilar medicine in the form of Accord Healthcare's version of filgrastim, a drug to treat the side effects of chemotherapy.

The original version of filgrastim is Amgen's Neupogen, but since its patent expired competitors can create a copy of the biological drug known as a biosimilar.

Other companies that have a version of filgrastim include Sandoz, which recently became the first company to have a biologic accepted for FDA review under the agency's biosimilars pathway.

The final recommendation was for a generic version of busulfan to be marketed by Fresenius Kabi Oncology. The guidance covers the drug's use as a conditioning treatment prior to conventional haematopoietic progenitor cell transplantation.

28th July 2014

From: Sales, Regulatory

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