EMA approves 8 new medicines for Europe

July 29 2013 | By Márcio Barra

EMA’s CHMP 22-25 July 2013 saw 8 new drugs obtaining a positive opinion for a marketing authorization (MA). Here is the rundown of approvals:

Approved marketing authorizations for new drugs:

Giotrif (afatinib), Boehringer Ingelheim International GmbH  –  Giotrif is an antineoplastic drug for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations. The drug is the first irreversible ErbB family blocker, a group of receptor tyrosine kinases overexpress in many cancers. This is the third drug to target EGFR mutations in NSCLC, joining erlotinib (Tarceva) and gefitinib (Iressa).

The CHMP’s positive opinion for Giotrif is based on data from the pivotal trial LUX-Lung,comparing afatinib to chemotherapy with pemetrexed/cisplatin. Results from the study showed that patients taking afatinib lived for almost one year without their tumour growing again versus just over half a year for those treated with pemetrexed/cisplatin.

Afatinib was recently approved for this indication in the United States, under the name Gilotrif.

Grastofil (filgrastim), Apotex Europe BV – Grastofil, a biosimilar of Neupogen (filgrastim), is a granulocyte colony-stimulating factor that regulates the production and release of functional neutrophils from the bone marrow for the treatment of neutropenia, a condition of an abnormally low number of white blood cells.  Clinical trials showed that Grastofil has a comparable quality, safety and efficacy profile than that of Neupogen.

The first biosimilar ever approved in Europe dates back to 2006, when Omnitrope (somatropin) was approved. Since then, a total of 14 biosimilar medicines were authorized

Vipidia (alogliptin), Takeda Pharma A/S. –  Alogliptin is a dipeptidyl peptidase 4 (DPP 4) inhibitor  that works by slowing the inactivation of incretin hormones, such as glucagon like peptide-1 (GLP-1), involved in regulating blood glucose levels. The drug is approved for the treatment of type 2 diabetes mellitus in combination with other glucose-lowering medicinal products.

Other DPP 4 inhibitors in the market include sitagliptin (Januvia; Merck & Co), saxagliptin (Komboglyze, Onglyza; AstraZeneca/Bristol-Myers Squibb), linagliptin (Jentadueto, Trajenta; Boehringer Ingelheim/Lilly), and vildagliptin (Eucreas, Galvus, Icandra, Jalra, Xiliarx, Zomarist; Novartis)

Incresync (alogliptin, pioglitazone), Takeda Pharma A/S – Incresync is fixed-dose combination of alogliptin with pioglitazone for the treatment of type 2 diabetes in adults. Pioglitazone is a thiazolidinedione, used to improve cells’ sensitivity to insulin. Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus, either as an adjunct therapy to diet and exercise or in combination with metformin.

Vipdomet (alogliptin, metformin), Takeda Pharma A/S – Vipdomet is another fixed-dose combination of alogliptin and a blood-glucose lowering product, this time metformin, for the treatment of type 2 diabetes in adults. Metformin is biguanide that decreases hepatic glucose production and intestinal absorption of glucose, and improves insulin sensitivity

These 3 formulations of alogliptin were approved in January in the United States and launched in last month as Nesina,Oseni, and Kazano, respectively, for use with diet and exercise to improve blood glucose control in adults with type 2 diabetes. Alogliptin was approved in April 2010 in Japan for the treatment of type 2 diabetes, under the brand name Nesina.

Alogliptin was actually supposed to be the first DPP-4 inhibitor to be licensed in the United States, but new cardiovascular safety requirements for all new diabetes medications issued by the FDA in 2008 forced Takeda to conduct new clinical trials, , while 3 competitors whose drugs were further back in development — sitagliptin (Januvia, Merck), saxagliptin (Onglyza, AstraZeneca/Bristol-Myers Squibb), and linagliptin (Tradjenta, Boehringer Ingelheim/Lilly) — were able to beat alogliptin to market.

Tybost (cobicistat), Gilead Sciences International Ltd. –  Cobicistat is a pharmacokinetic enhancer of the human immunodeficiency virus-1 (HIV-1) protease inhibitors atazanavir and darunavir. By inhibiting CYP3A-mediated metabolism, the drug enhances the systemic exposure of CYP3A substrates (such as atazanavir or darunavir) that have limited oral bioavailability and a short half-life due to CYP3A-dependent metabolism. The drug by itself does not fight the HIV. Its only purpose is to boost the function of the aforementioned HIV medicines.

The European recommendation contrasts with a rebuff for the Gilead product from the FDA in April, alongside elvitegravir.

Ultibro Breezhaler / Xoterna Breezhaler (glycopyrronium bromide, indacaterol), Novartis Europharm Ltd – Ultibro Breezhaler and Xoterna Breezhaler are a first in class once-daily dual bronchodilators, combining Indacaterol, a beta-2-adrenergic agonist (LABA) that relaxes the muscles of the airways, and glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA) licenced from Vectura that dilates the airways. The drug was approved as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

LAMA/LABA combinations are expected to become major sellers in the future, and this approval gives Novartis a head start from companies like GlaxoSmithKline who are also working on this combination.

The CHMP’s decision was supported by data from five trials from the IGNITE clinical programme. Novartis noted that in the trials, Ultibro demonstrated significant improvements in bronchodilation compared to its two components alone, Pfizer’s Spiriva (tiotropium) and placebo.

US filing for this treatment is expected at the end of 2014.

For the remaining decisions, please check EMA’s website

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