The European Medicines Agency, said Friday it has adopted a
positive opinion on Multaq (dronedarone hydrochloride), from
Sanovi-Aventis, indicated in adult clinically stable patients with
a history of, or current non-permanent atrial fibrillation (AF), to
prevent recurrence of AF or to lower ventricular rate. The review
of Multaq began on July 23, 2008, with an active review time of 183
days.
MAIN FACTS:
-Positive opinions for new medicines
-The Committee adopted positive opinions, recommending the
granting of a marketing authorisation, for the following new
medicines:
-Onbrez Breezhaler (indacaterol maleate), Hirobriz Breezhaler
(indacaterol maleate) and Oslif Breezhaler (indacaterol maleate),
all from Novartis Europharm Ltd (NVS), indicated for the
maintenance bronchodilator treatment of airflow obstruction in
adult patients with chronic obstructive pulmonary disease (COPD).
The review of Onbrez Breezhaler began on 28 January 2009, with an
active review time of 178 days. The review of Hirobriz Breezhaler
and Oslif Breezhaler began on 26 July 2009 with an active review
time of 60 days.
-Prevenar 13 (pneumococcal polysaccharide conjugated vaccine,
13-valent adsorbed), from Wyeth Lederle Vaccines S.A. (WYE),
intended for prevention of invasive disease, pneumonia and acute
otitis media caused by Streptococcus pneumoniae. The review of
Prevenar 13 began on 24 December 2009 with an active review time of
204 days.
-Zutectra (human hepatitis B immunoglobulin), from Biotest
Pharma GmbH (BIO.XE), intended for the prevention of Hepatitis B
virus re-infection in HBV-DNA negative patients ≥ 6 months after
liver transplantation for Hepatitis B-induced liver failure. The
review of Zutectra began on 19 November 2008, with an active review
time of 204 days.
-Positive opinions for ‘informed consent’ applications
-The Committee adopted positive opinions for Rivastigmine 1 A
Pharma (rivastigmine), from 1 A Pharma GmbH, Rivastigmine HEXAL
(rivastigmine), from Hexal AG and Rivastigmine Sandoz
(rivastigmine), from Sandoz Pharmaceuticals GmbH, for which an
‘informed consent’ application was submitted.
-The products are intended for the symptomatic treatment of mild
to moderately severe Alzheimer’s dementia and for the treatment of
mild to moderately severe dementia in patients with idiopathic
Parkinson’s disease.
-’Informed consent’ applications require that reference is made
to an authorised medicinal product and that the marketing
authorisation holder of the referenced product has given consent to
the use of their dossier in the application procedure.
-Positive opinions for generic medicines
-The Committee adopted positive opinions for the following
generic medicines, for which a reference medicine is already
authorised in the European Union:
-Irbesartan Hydrochlorothiazide Teva (Irbesartan
Hydrochlorothiazide), from Teva Pharma B.V. (TEVA), a generic of
CoAprovel, indicated for the treatment of hypertension.
-Lamivudine Teva Pharma BV (lamivudine), from Teva Pharma B.Va
generic of Epivir, indicated as part of antiretroviral combination
therapy for the treatment of Human Immunodeficiency Virus (HIV)
infected adults and children.
-Olanzapine Glenmark Europe (olanzapine), Olanzapine Glenmark
(olanzapine), from Glenmark Generics (Europe) Ltd, and Olazax
Desperzi (olanzapine) and Olazax (olanzapine), from Glenmark
Phamaceuticals s.r.o., all generics of Zyprexa, indicated for the
treatment of schizophrenia and moderate to severe manic
episode.
-Sidenafil Actavis (sildenafil citrate), from Actavis Group PTC
and Sidenafil TEVA (sildenafil citrate) from Teva Pharma B. V.,
both generics of Viagra, intended to treat erectile
dysfunction.
-Nevirapine Teva (nevirapine, anhydrous), from Teva Pharma B.V.,
a generic of Viramune, indicated for treatment of HIV-1 infected
adults, adolescents, and children of any age.
-The Committee has approved an extension of indication for
Tamiflu (oseltamivir), from Roche Registration Ltd. (RHHBY), to
include treatment of children less than 6 months of age during
pandemic influenza and post-exposure prophylaxis for children less
than 1 year of age.
-Tamiflu is currently indicated for the treatment of influenza
in patients one year of age and older who present with symptoms
typical of influenza, when influenza virus is circulating in the
community.
-It is also indicated for the treatment of children 6 to 12
months of age during a pandemic influenza outbreak.
-In parallel the Committee has approved instructions to prepare
home and pharmacy extemporaneous formulations from Tamiflu 30, 45
and 75 milliong capsules and dosing recommendations from these
extemporaneous formulations for children under 1 year of age.
-Additional information including the recommended updated
product information in English will be published shortly.
-The Committee gave positive opinions for applications for the
extension of indication, adding new treatment options, for the
following medicines:
-Efficib, Janumet and Velmetia (sitagliptin phosphate
monohydrate / metformin hydrochloride), and Januvia, Tesavel and
Xelevia (sitagliptin), from Merck Sharp & Dohme Ltd, to extend
the indication of these medicines to include combination therapy
with insulin. These medicines are currently authorised for the
treatment of type-2 diabetes mellitus, as an adjunct to diet and
exercise, in dual combination with metformin or in triple
combination with metformin and sulphonylurea or with a PPARγ
agonist and metformin when diet and exercise plus dual therapy with
these agents do not provide adequate glycaemic control.
-Corlentor (ivabradine) and Procoralan (ivabradine), both from
Les Laboratoires Servier, to extend the indication to use the
medicine in combination with beta-blockers in patients inadequately
controlled with an optimal beta-blocker dose and whose heart rate
is > 60 bpm. Corlentor and Procoralan are currently indicated
for symptomatic treatment of chronic stable angina pectoris in
coronary artery disease patients with normal sinus rhythm, in
patients unable to tolerate or with a contra-indication to the use
of beta-blockers, or in combination with beta-blockers in patients
inadequately controlled with an optimal beta-blocker dose and whose
heart rate is > 60 bpm.
-Yondelis (trabectedin), from Pharma Mar S.A., to extend the
indication of Yondelis in combination with Caelyx to the treatment
of patients with relapsed platinum-sensitive ovarian cancer.
Yondelis is currently indicated for the treatment of patients with
advanced soft tissue sarcoma, after failure of anthracyclines and
ifosfamide, or who are unsuited to receive these agents.
-PegIntron and ViraferonPeg (peginterferon alfa-2 billion), from
Schering-Plough Europe, to extend the therapeutic indication of
combination therapy with ribavirin to include treatment of the
paediatric population and to include the treatment of adult
patients with compensated cirrhosis. PegIntron and ViraferonPeg are
currently indicated for the treatment of adult patients with
chronic hepatitis C who have elevated transaminases without liver
decompensation and who are positive for serum HCV-RNA or anti-HCV,
including naïve patients with clinically stable HIV co-infection.
It is also indicated for the treatment of hepatitis C in adults
patients who have failed previous treatment with interferon alpha
(pegylated or non-pegylated) in combination therapy with
ribavirin.
-The same extension of indication applies to Rebetol (ribavirin)
used in combination with peginterferon alfa-2 billion from
Schering-Plough Europe.
-The European Medicines Agency has completed a review on the
risk of osteonecrosis of the jaw associated with the use of
bisphosphonates. The CHMP was asked to give a scientific opinion
on:
-the criteria that define osteonecrosis of the jaw related to
bisphosphonates;
-how bisphosphonates may cause osteonecrosis of the jaw;
-whether the risk of osteonecrosis of the jaw is greater with
some bisphosphonates or for some groups of patients;
-the measures that could be taken to minimise this risk.
-The CHMP has concluded that there is an increased risk of
osteonecrosis of the jaw in patients using these medicines.
-However, further studies should be carried out to better
identify the factors that increase the risk and the measures needed
to minimise it.
-The review was carried out under Article 5(3) of Regulation
(EC) 726/2004, opinion on any scientific matter concerning the
evaluation of medicinal products for human use.
-Under this type of procedure the CHMP can give a scientific
opinion on any matter concerning the evaluation of medicinal
products for human use
-The CHMP initiated two referral procedures under Article 107
for:
-Propacetamol (injectable), only approved in France for the
symptomatic treatment of pain and fever further to the decision to
withdraw the product from the market. The withdrawal was due to
risks of serious hypersensitivity reactions, cases of thrombosis
and administration site reactions.
-Antiadiposo (iodocasein/thiamine), approved only in Italy for
treatment of obesity further to the decision to suspend the product
from the market due to cases of hypertiroidism and
tireoxicosis.
-The reviews are carried out under Article 107 of the Community
code relating to medicinal products for human use (Directive
2001/83/EC). These types of procedure are initiated in cases where
a Member State withdraws, suspends or changes the marketing
authorisation of a nationally authorised medicine as a result of
the evaluation of safety data.
-It provides for a harmonised European approach because the CHMP
is asked to prepare an opinion on whether or not the regulatory
actions should be implemented throughout the European Union.
-A more detailed CHMP meeting report will be published
shortly.
-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296; ian.walker@dowjones.com