CHMP Recommends Marketing Authorization For Trajenta, Votubia

The Committee for Medicinal Products for Human Use, or CHMP, said Friday that it has adopted positive opinions recommending the granting of marketing authorizations for Trajenta-linagliptin, from Boehringer Ingelheim International GmbH, intended for the treatment of type 2 diabetes mellitus to improve glycaemic control in adults.

MAIN FACTS:

-CHMP also it adopted positive opinions recommending the granting of marketing authorizations for Votubia-everolimus, an orphan medicine from Novartis Europharm Ltd, intended for the treatment of patients aged three years and older with subependymal giant-cell astrocytoma associated with tuberous sclerosis complex.

-CHMP recommended granting a conditional marketing authorization for Votubia, which means that further evidence on the medicinal product is awaited.

-Committee adopted negative opinions recommending marketing authorizations shouldn't be granted for the following orphan medicines:

* Bronchitol-mannitol, from Pharmaxis Pharmaceuticals Ltd, intended for the treatment of adult patients with cystic fibrosis.

* Luveniq-voclosporin, from Lux Biosciences GmbH, intended for the treatment of chronic non-infectious uveitis.

-Committee adopted a negative opinion for the orphan medicine Glybera-alipogene tiparvovec, from Amsterdam Molecular Therapeutics B.V. not granting a marketing authorization.

-The Committee adopted positive opinions for Entacapone Orion-entacapone and Levodopa/Carbidopa/Entacapone Orion, both from Orion Corporation, intended for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations.

-Committee adopted positive opinions for the following applications for extension of the therapeutic indications. This adds new treatment options for the following medicines that are already authorized in the EU:

* Kiovig human normal immunoglobulin, from Baxter AG, to include the treatment of multifocal motor neuropathy.

* Retacrit epoetin zeta, from Hospira U.K. Ltd, to include the reduction of allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery.

* Synflorix pneumococcal polysaccharide conjugate vaccine absorbed, from GlaxoSmithKline Biologicals S.A., to increase the upper age limit for children from two-five years of age.

-Following re-examination of its previous negative opinion, Committee adopted a final positive opinion, recommending the extension of indication for Vectibix panitumumab, from Amgen Europe B.V., to include the use of panitumumab in combination with specific chemotherapy in patients with wild-type KRAS metastatic carcinoma of the colon or rectum.

-Committee is currently reviewing results from pharmacoepidemiological studies, non-clinical and clinical data and post-marketing reports on pioglitazone-containing medicines and the occurrence of bladder cancer to assess their impact on the balance of benefits and risks of these medicines.

-CHMP will finalize its review in July and make recommendations on the future use of these medicines.

-Committee concluded that the benefits of systemic nimesulide-containing medicines continue to outweigh their risks in the treatment of patients with acute pain and primary dysmenorrhoea.

-Committee recommended restricting the use of dexrazoxane-containing medicines to adult patients with advanced or metastatic breast cancer who have already received a certain amount of the anthracyclines doxorubicin and epirubicin to treat their cancer; Committee also recommended this medicine shouldn't be used in children.

-Committee recommended harmonization of the prescribing information for the antifungal medicine Diflucan fluconazole, from Pfizer group of companies; medicine is used to treat various fungal infections, including mucosal and invasive candidiasis, genital candidiasis, crypotococcal meningitis, dermatomycosis, coccidiodomycosis and onychomycosis.

-Committee completed a review of the clinical studies performed in support of the marketing authorization applications for the hybrid medicines Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names goserelin, 3.6 mg implant.

-The Committee concluded that the bioanalytical studies couldn't be relied upon, because they weren't conducted in accordance with good clinical practice requirements.

-Committee has begun looking at dosing recommendations of the anti-tuberculosis medicines isoniazide, rifampicine, pyrazinamide, ethambutol and rifabutin in children.

-Committee will now review all of the available literature and give an opinion on the optimal dosing regimen for paediatric patients in the E.U., taking account of the current WHO recommendation.

-By Razak Musah Baba, Dow Jones Newswires; 44-20-7842-9275; [e-mail]