The European Medicines Agency's Committee for Medicinal Products
for Human Use, or CHMP, announced Friday positive opinions for new
medicines from GlaxoSmithKline Biologicals (GSK.LN), in particular
Pandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted) (H5N1 split virion, inactivated, adjuvanted with AS03),
from GSK Biologicals, a duplicate of Pandemrix, frm GSK
Biologicals, as a part of its regular monthly review.
MAIN FACTS:
-CHMP adopted positive opinions, recommending the granting of a
marketing authorisation, for the following medicines:
-Arcalyst (rilonacept), from Regeneron U.K. Limited, indicated
for the treatment of adults and children aged 12 years and older
with severe symptoms of Cryopyrin-Associated Periodic Syndromes
(CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS)
and Muckle-Wells Syndrome (MWS). CAPS is a rare, inherited
condition causing recurrent fever, rash and joint pain. Arcalyst is
the 57th orphan medicine to receive a positive opinion from the
CHMP. The review began on 23 July 2008, with an active review time
of 197 days.
-Exforge HCT (amlodipine
besylate/valsartan/hydrochlorothiazide), Copalia HCT (amlodipine
besylate/valsartan/hydrochlorothiazide), Imprida HCT (amlodipine
besylate/valsartan/hydrochlorothiazide) and Dafiro HCT (amlodipine
besylate/valsartan/hydrochlorothiazide), all from Novartis
Europharm Limited, indicated for the treatment of essential
hypertension, as substitution therapy in adult patients whose blood
pressure is adequately controlled on the combination of amlodipine,
valsartan and hydrochlorothiazide. The review for Exforge HCT began
on 24 September 2008, with an active review time of 206 days. The
review for the three other products began on 29 March 2009, with an
active review time of 89 days and was aligned with that of Exforge
HCT.
-Ilaris (canakinumab), from Novartis Europharm Ltd., indicated
for the treatment of adults, adolescents and children aged 4 years
and older with Cryopyrin-Associated Periodic Syndromes (CAPS),
including Muckle-Wells Syndrome (MWS), Neonatal-Onset Multisystem
Inflammatory Disease (NOMID) / Chronic Infantile Neurological,
Cutaneous, Articular Syndrome (CINCA), and severe forms of Familial
Cold Autoinflammatory Syndrome (FCAS). CAPS is a rare, inherited
condition causing recurrent fever, rash and joint pain. Ilaris is
the 58th orphan medicine to receive a positive opinion from the
CHMP. The review began on 24 December 2008, with an active review
time of 176 days.
-Ratioepo (epoetin theta), Eporatio (epoetin theta), both from
Ratiopharm GmbH, and Biopoin (epoetin theta), from CT Arzneimittel
GmbH, indicated for the treatment of symptomatic anaemia associated
with chronic renal failure in adult patients and for the treatment
of symptomatic anaemia in adult cancer patients with non-myeloid
malignancies receiving chemotherapy. Reviews began on June 25,
2008, with an active review time of 205 days.
-Resolor (prucalopride), from Movetis NV, indicated for the
symptomatic treatment of chronic constipation in women in whom
laxatives fail to provide adequate relief. The review began on 28
May 2008, with an active review time of 206 days. Positive opinions
for 'informed consent' duplicate applications The Committee adopted
positive opinions for duplicate applications for three pandemic
influenza mock-up vaccines.
-Positive opinions were adopted for duplicate applications of
the following mock-up vaccines:
-Pandemic Influenza Vaccine H5N1 Baxter AG (whole virion, Vero
cell derived, inactivated), from Baxter AG, a duplicate of
Celvapan, from Baxter AG.
-Foclivia (H5N1 virus surface antigens), from Novartis Vaccines
and Diagnostics S.r.L., a duplicate of Focetria, from Novartis
Vaccines and Diagnostics S.r.L.
-Pandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted) GlaxoSmithKline Biologicals (H5N1 split virion,
inactivated, adjuvanted with AS03), from GSK Biologicals, a
duplicate of Pandemrix, from GSK Biologicals.
-The Committee also adopted a positive opinion for Alendronate
sodium and colecalciferol, MSD, from Merck Sharp & Dohme Ltd, a
duplicate application to Fosavance, which is already authorised in
the E.U. for the treatment of postmenopausal osteoporosis in
patients at risk of vitamin D insufficiency.
-When submitting 'informed consent' duplicate applications,
applicants can make reference to a medicine that is already
authorised in the E.U., provided they have obtained consent from
the marketing authorisation holder of the reference medicine to do
so.
-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:
-Enyglid (repaglinide), and Repaglinide Krka (repaglinide), both
from Krka, d.d., Novo mesto, generics of Novonorm, intended to
treat patients with type-2 diabetes.
-Irbesartan Teva (irbesartan), from Teva Pharma B.V., a generic
of Aprovel, intended for the treatment of essential
hypertension.
-Lamivudine Teva (lamivudine), from Teva Pharma B.V., a generic
of Zeffix, intended for the treatment of chronic hepatitis B in
adults.
-Clopidogrel MYLAN Pharma (clopidogrel, as besilate), from Mylan
S.A.S., a generic of Plavix, intended for the prevention of
atherothrombotic events in patients suffering from myocardial
infarction or established peripheral arterial disease.
-The Committee adopted two negative opinions, recommending that
marketing authorisations for the following two medicines should be
refused:
-Gemesis (bercaplermin), from Biomimetic Therapeutics Ltd,
intended for the treatment of periodontally related defects.
-Milnacipran Pierre Fabre Médicament (milnacipran) and Impulsor
(milnacipran), both from Pierre Fabre Médicament, intended for the
treatment of fibromyalgia syndrome.
-The Committee gave positive opinions for applications for the
extension of indication, adding new treatment options, for the
following medicines:
-Isentress (raltegravir), from Merck Sharp & Dohme Ltd, to
extend the indication to include antiretroviral-treatment naïve
adult patients. Isentress is currently authorised as
combination-therapy with other anti-retroviral medicines for the
treatment of human immunodeficiency virus (HIV-1) infection in
treatment-experienced adult patients.
-Keppra (levetiracetam), from UCB S.A., to extend the age range
for use of the medicine to children and infants from 1 month of age
in the indication of adjunctive treatment of partial seizures
(fits) with or without secondary generalisation. Keppra is
currently authorised in this indication in patients from 4 years of
age. It is also currently authorised as monotherapy to treat
partial onset seizures with or without secondary generalisation in
patients from 16 years of age with newly diagnosed epilepsy. Keppra
is also authorised as combination therapy to treat myoclonic
seizures in patients from 12 years of age with juvenile myoclonic
epilepsy and primary generalised tonic-clonic seizures in patients
from 12 years of age with idiopathic generalised epilepsy.
-Mabthera (rituximab), from Roche Registration Ltd, to extend
the indication to include the treatment of relapsed/refractory
chronic lymphocytic leukaemia. Mabthera is currently authorised for
the treatment of Non-Hodgkin's Lymphoma, first-line treatment of
patients with chronic lymphocytic leukaemia (CLL) and second-line
treatment of adult patients with severe active rheumatoid
arthritis.
-Torisel (temsirolismus), from Wyeth Europa Ltd., to extend the
indication to include the treatment of Uadult patients with
relapsed and/or refractory Umantle cell lymphoma. Torisel is
currently authorised for the first-line treatment of patients with
advanced renal cell carcinoma.
-The Committee adopted a negative opinion, recommending the
refusal of an extension of indication for Erbitux (cetuximab), from
Merck KGaA. The indication applied for was first-line treatment of
patients with epidermal growth factor receptor (EGFR)-expressing
advanced or metastatic non-small cell lung cancer in combination
with platinum-based chemotherapy. Erbitux is currently authorised
for single and combination treatment of patients with
EGFR-expressing metatstatic colorectal cancer and as combination
therapy for the treatment of patients with squamous cell cancer of
the head and neck.
-Finalising a re-examination procedure for Lyrica (pregabalin),
from Pfizer Limited, the Committee adopted a final negative
opinion, recommending that the indication should not be extended to
the treatment of fibromyalgia in adults.
-Following review of all available information on a possible
relationship between insulin analogues, in particular insulin
glargine, and the risk of cancer, the Committee concluded that the
available data does not provide a cause for concern and that
changes to the prescribing advice are therefore not necessary.
-Insulin glargine is a long-acting insulin analogue, authorised
in the European Union (E.U.) as Lantus and Optisulin, for the
treatment of adults, adolescents and children aged six years or
above with diabetes, when treatment with insulin is required.
-The CHMP adopted an opinion for Arimidex (anastrozole), from
AstraZeneca AB, to reflect new clinical data on the use of
anastrozole in the treatment of short stature in pubertal boys with
growth hormone deficiency in association with exogenous growth
hormone, and in the treatment of testotoxicosis. These data were
generated in accordance with an agreed paediatric investigation
plan (PIP). AstraZeneca AB had applied for an extension of
indication to include treatment of short stature in pubertal boys
with growth hormone deficiency in association with exogenous growth
hormone. The Committee's opinion was that the data do not support
the authorisation of the medicine for children. However the
information on the paediatric studies will be included in the
product information. This opinion will be transformed into a
decision by the European Commission, after which the Member States
must implement the changes adopted. The opinion was adopted in
accordance with Article 29 of the Paediatric Regulation
(1901/2006).
-Re-examination of referral procedure for Ciclosporin IDL
concluded The Committee finalised a re-examination procedure for a
referral under Article 29 of Directive 2001/83/EC, as amended, for
Ciclosporin IDL and associated names (ciclosporin), 25 mg, 50 mg
and 100 mg, capsules from International Drug Licensing (IDL),
indicated in transplantation and auto-immune diseases. The
Committee concluded that Ciclosporin IDL is not bioequivalent to
the reference product and recommended the refusal of the Marketing
Authorisation in the Concerned Member States and the suspension of
the Marketing Authorisation for Ciclosporin IDL in the Member
States where the product is currently authorised. Referrals under
Article 29 of Directive 2001/83/EC, as amended are initiated by one
or more Member States in cases where an agreement cannot be reached
in the context of the mutual recognition procedure or the
ecentralised procedure.
-Referral procedure for Meronem and associated names concluded
The CHMP concluded a referral procedure under Article 30 of
Directive 2001/83/EC, as amended, for Meronem and associated names
(meropenem), from AstraZeneca group of companies and associated
companies, used as an anti-infective.
-The CHMP adopted a harmonised product information. This type of
procedure is initiated with a view to harmonising product
information for medicinal products authorised at Member State
level.
-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296; ian.walker@dowjones.com