The Committee for Medicinal Products for Human Use, or CHMP, said Friday it has adopted a positive opinion on Vpriv (velaglucerase alfa), from Shire Pharmaceutical Ireland Ltd, an orphan medicine intended for the treatment of Gaucher disease adding that Vpriv might constitute an alternative treatment option for this condition.

MAIN FACTS:

-Positive opinions for new medicines adopted:

* Brinavess (vernakalant), from Merck Sharp & Dohme Ltd, intended for the rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults.

* Rapiscan (regadenoson), from Gilead Sciences International Ltd, intended as pharmacological stress agent for radionuclide myocardial perfusion imaging.

* Ruconest (conestat alfa), previously known as Rhucin, from Pharming Group N.V., an orphan medicine intended for the treatment of angioedema attacks.

* Sycrest (asenapine), from N.V. Organon, intended for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.

-The Committee adopted a positive opinion recommending the granting of a marketing authorization for PecFent (fentanyl), from Archimedes Development Ltd, intended for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. PecFent is a 'hybrid generic' medicine.

-Positive opinions for generic medicines adopted:

* Ibandronic Acid Teva (ibandronic acid), from Teva Pharma B.V. The 50--mg tablets are intended for the prevention of skeletal events in patients with breast cancer and bone metastases, and the 150--mg tablets are intended for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Ibandronate Teva 50 mg is a generic of Bondronat, and Ibandronate Teva 150 mg is a generic of Bonviva.

* Telmisartan Actavis (telmisartan), from Actavis Group PTC ehf, intended for the treatment of essential hypertension and reduction of cardiovascular morbidity. Telmisartan Actavis is a generic of Micardis.

-Positive opinions for extensions of indications adopted:

* Byetta (exenatide), from Eli Lilly Nederland B.V., to include treatment of type 2 diabetes mellitus in combination with thiazolidinedione (with or without metformin).

* Gardasil and Silgard (human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)), from Sanofi Pasteur MSD SNC and Merck Sharp & Dohme Ltd, to include the prevention of premalignant genital lesions, cervical cancer and external genital warts in mid-adult women, from the age of 26 to 45 years.

-Committee confirmed its previous negative opinion and adopted a final negative opinion, recommending that Zeftera (ceftobiprole medocaril), from Janssen-Cilag International NV, should not be granted a marketing authorization. Zeftera is an antibiotic, intended for the treatment of complicated skin and soft-tissue infections.

-Committee completed arbitration procedures initiated because of disagreement among E.U. Member States regarding the authorization of Fortipan Combi D and Norsed Combi D (risedronate sodium, calcium carbonate and colecalciferol) and associated names, from Procter & Gamble Pharmaceuticals and Sanofi-Aventis S.p.A.; Committee concluded that the combination pack will simplify the correct dosage regimen and didn't consider the demonstration of improved compliance to be an absolute requirement for the approval of these combination products.

-Committee concluded that the benefit-risk profile of these medicines was positive and recommended that marketing authorizations should be granted.

-Committee completed an arbitration procedure initiated because of disagreement among E.U. Member States regarding the extension of the therapeutic indications for Genotropin (somatropin) and associated names, from Pfizer ApS; These medicines are indicated for treatment of children with growth disturbances and adults with growth hormone deficiency.

-The Committee recommended harmonization of the prescribing information for Atacand Plus (candesartan/hydrochlorothiazide) and associated names, from AstraZeneca group of companies.

-Committee started a review of the benefits and risks of Invirase (saquinavir), in view of the results of a study conducted by the marketing authorization holder, Roche Registration Ltd, investigating the proarrhythmic effect of ritonavir-boosted saquinavir in healthy volunteers.

-Review of the medicine's benefits and risks has been initiated to discuss any additional measures necessary to ensure the safe and effective use of Invirase and to determine how to balance the risks and benefits of the medicine. Ritonavir-boosted Invirase is indicated as combination treatment of HIV-infected adult patients.

- Committee has begun looking at the possible risk of cancer in patients taking angiotensin II receptor inhibitors. This follows the publication of a meta-analysis reviewing nine randomized controlled trials involving almost 95,000 patients, which suggests that these medicines may be linked with a modestly increased risk of new diagnoses of cancer when compared with placebo or other heart medicines.

-By Ian Walker, Dow Jones Newswires; 44-20-7842-9296; ian.walker@dowjones.com