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EMA backs 15 new medicines for use in EU

Includes new treatments from Gilead, Lilly, Boehringer, AstraZeneca and Janssen
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Drug regulator the European Medicines Agency (EMA) has recommended 15 new medicines be available to patients in the EU.

Leading the latest set of positive opinions from the EMA's Committee for Medicinal Products for Human Use (CHMP) is the combination hepatitis C drug Harvoni (sofosbuvir / ledipasvir) from Gilead Sciences.

The drug combines Gilead's hugely successful recent launch Sovaldi with investigational drug ledipasvir and will be available for the treatment of chronic hepatitis C in adults.

Two new recommendations for Lilly
Elsewhere, the CHMP recommended two new drugs from Lilly, including the oncology drug Cyramza (ramucirumab) as a treatment for gastric cancer. The drug was approved in this indication in the US in April, while Lilly is also investigating its potential in lung cancer and colorectal cancer.

Lilly also won backing for the GLP-1 agonist Trulicity (dulaglutide) for the treatment of type 2 diabetes. It is set to join a competitive market led by Novo Nordisk's Victoza (liraglutide) and AstraZeneca's Byetta/Bydureon (exenatide), which was formerly owned by Lilly.

Boehringer in cancer
Germany-based Boehringer Ingelheim recorded a recommendation for a new cancer drug with the CHMP backing Vargatef (nintedanib) as a treatment for non-small cell lung cancer (NSCLC).

The drug is the second oncology medicine to be developed by Boehringer after the personalised treatment Giotrif/Gilotrif (afatinib), which is also recommended as a treatment for NSCLC.

AstraZeneca and Almirall
There was good news for AstraZeneca (AZ), which received positive opinions for two of its medicines.

The company's Moventig (naloxegol) is now on course for use in the EU to treat patients with opioid-induced constipation, while the chronic obstructive pulmonary disease (COPD) treatment drug aclidinium / formoterol fumarate dehydrate was also recommended.

Aclidinium / formoterol fumarate, which is set to be marketed as Brimica Genuair or Duaklir Genuair depending on the country, was developed by Almirall but will be owned by AZ once its $2bn deal to buy Almirall's respiratory portfolio is completed.

Janssen's HIV treatment
Janssen looks set to expand its efforts in HIV treatment with a recommendation for Rezolsta, a combination of the company's Prezista (darunavir) and Gilead's boosting agent cobicistat.

The CHMP also recommended that Prezista has its licence extended to cover co-administration with cobicistat and for a wider paediatric use.

Cushing's syndrome, neutropenia and lymph nodes
Other new drugs recommended by the CHMP include Laboratoire HRA Pharma's Ketoconazole HRA as a treatment for Cushing's syndrome; Navidea Biopharmaceuticals' Lymphoseek (tilmanocept) for the delineation and localisation of sentinel lymph nodes; and Teva's Egranli (balugrastim) to treat chemotherapy-induced neutropenia

Generics and hybrids
The CHMP recommended one new generic medicines: Tadalafil Mylan for the treatment of dysfunction in adult males. Tadalafil is the active ingredient of Lilly's Cialis

In addition to the positive opinion for Egranli, Teva managed recommendation for three new hybrid treatments for respiratory diseases. They are all combinations involving budesonide.

Article by
Thomas Meek

29th September 2014

From: Sales, Regulatory



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