EU Panel Adopts Positive Opinion On Vpriv From Shire
25 Juin 2010 - 12:04PM
Dow Jones News
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