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Boehringer’s first cancer drug leads EMA recommendations

Afatinib recommended for lung cancer under brand name Giotrif

Boehringer Ingelheim headquarters

Boehringer Ingelheim's first oncology medicine Giotrif was the stand-out recommendation in the latest set of opinions from the European Medicines Agency (EMA).

The EMA's Committee for Medicinal Products for Human Use (CHMP) backed the drug for use in the treatment of lung cancer in a list of opinions that also saw recommendations for medicines from Novartis, Takeda and Gilead.

The endorsement for Giotrif (afatinib) covers the drug's use in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have the epidermal growth factor receptor (EGFR) gene mutation, which is present in about 10 per cent of people with NSCLC.

It caps a good month for Boehringer, which won US approval for the drug under the brand name Gilotrif two weeks ago, adding to the company's list of therapy areas, which so far include chronic obstructive pulmonary disease (COPD), anticoagulation, HIV, Parkinson's disease and diabetes.

In the US, the drug is approved alongside a companion diagnostic to help determine if a patient's lung cancer cells express the EGFR mutations, whereas the EMA recommendation just includes the requirement that Giotrif be initiated and supervised by a physician experienced in the use of anti-cancer therapies.

Novartis COPD inhaler recommended in EU
Elsewhere among the CHMP's recommendations, Novartis received backing for the Ultibro Breezhaler as a once-daily maintenance treatment to relive symptoms in adults with the lung condition COPD.

The product, which is to be marketed as Xoterna Breezhaler in some countries, combines indacaterol - a long-acting beta-adrenergic agonist (LABA) present in Novartis' Onbrez - and glycopyrronium bromide - a long-acting muscarinic antagonist (LAMA) present in Novartis' Seebri.

It is the latest in a series of LABA/LAMA combination products to be developed for COPD, with GlaxoSmithKline's (GSK) Anoro, which combines umeclidinium bromide and vilanterol, currently under review in the US and Europe.

CHMP backs Tybost in HIV
Gilead also received good news, with the CHMP backing the use of Tybost (cobicistat) in the treatment of patients with HIV.

The drug is to be used alongside a protease inhibitor, such as Bristol-Myers Squibb's Reyataz (atazanavir) or Tibotec's Prezista (darunavir), in order to enhance the lifespan of these drugs.

Cobicistat is already recommended by the EMA as part of Gilead's combination HIV treatment Stribild, which offers a less complicated treatment option for patients.

The European recommendation is in contrast to the stance taken by the US Food and Drug Administration (FDA), which refused to back Gilead's cobicistat and elvitegravir as monotherapies in treatment regimens due to problems with Gilead's documentation.

Diabetes drugs and biosimilars
Other new drugs recommended by the CHMP included Takeda's DPP-4 inhibitor Vipidia (alogliptin) for the treatment of type 2 diabetes, as well as two combination treatments featuring this drug.

These are Incresync, which combines alogliptin with Takeda's thiazolidinedione Actos (pioglitazone), and Vipdomet, which combines alogliptin with the biguanide metformin.

Vipidia is Takeda's entrance onto the DPP-4 market, which already includes big-selling products, such as Merck & Co's Januvia, Lilly and Boehringher's Tradjenta and Bristol-Myers Squibb and AstraZeneca's Onglyza.

The final drug to receive a CHMP recommendation was Grastofil  - a biosimilar version of Amgen's Neupogen (filgrastim) marketed by Apotex.

30th July 2013

From: Sales

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