The Committee fit Curative Products fit Human Use (CHMP) concluded the review of non-selective non-steroidal anti-fiery drugs (NSAIDs), which was initiated during the September 2006 meeting. A statement will be issued on Tuesday 24 October at 10h00 (London time).
Prime marketing authorisation applications
The Committee gave four positive opinions on approve marketing authorisation applications, including two opinions by reason of medicinal products that are intended for the treatment of patients suffering from rare diseases:
– The Body recommended the granting of a conditional marketing authorisation in the interest Diacomit (stiripentol), from Laboratoires Biocodex, appropriate for the treatment of severe myoclonic epilepsy in infants in conjunction with clobazam and valproate. Conditional marketing authorisation has been recommended on the acclimate that further evidence on the subject of efficacy of stiripentol in combination with summit safe doses of clobazam and valproate, and on the bioavailability of Diacomit sachets compared to capsules is provided at a later fake. The EMEA wish re-assess Diacomit annually to confirm that the benefit-risk balance remains peremptory. Diacomit is the 32nd orphan medicinal product to come into a positive CHMP thought. EMEA review began on 18 May 2005 with an quick review time of 201 days.
– The Committee recommended the granting of a marketing authorisation under exceptional circumstances for Elaprase (idursulfase), from Shire Human Genetics Therapies AB, for the long-stretch treatment of patients with Tracker syndrome (Mucopolysaccharidosis II, MPS II). Elaprase is the 33rd orphan curative by-product to receive a positive CHMP opinion. EMEA review began on 28 December 2006 with an spry review every so often old-fashioned of 207 days. Marketing authorisation high exceptional circumstances may be granted participant to certain specific obligations, to be reviewed annually. In the case of Elaprase, this relates to the fact that the indication applied in requital for is so rare that the applicant cannot reasonably be expected to provide extensive data on the shelter and efficacy of the healing product.
– Tandemact (pioglitazone hydrochloride/glimepiride), from Takeda Europe R & D Centre Ltd, is recommended for the treatment of patients with type-2 diabetes mellitus who be conspicuous narrow-mindedness to metformine or for whom metformin is contraindicated and who are already treated with a composition of pioglitazone and glimepiride. EMEA over again began on 17 August 2005 with an active review ease of 196 days.
– Adrovance (alendronic acid and colecalciferol), from Merck Calculating & Dohme Ltd, is recommended for the treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency. Adrovance is the same medicinal product as Fosavance, also from Merck Sharp & Dohme Ltd, which is already authorised in the European Togetherness. EMEA review began on 21 July 2006 with an effective reconsideration time of 89 days.
Lifting of conditional marketing authorisation
The Committee recommended to inducement the conditional marketing authorisation for Sutent (sunitinib malate), from Pfizer Ltd. Sutent was the first iatrical product to be granted a conditional marketing authorisation in the European Coherence. It is currently indicated after the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumours after failure of imatinib mesylate treatment scheduled to resisters or intolerance, and advanced and/or metastatic renal cell carcinoma (MRCC) after deterioration of interferon alfa or interleukin-2 therapy.
The marketing authorisation was granted under the condition that the marketing authorisation holder would provide in addition comprehensive data on Sutent’s aftermath in terms of relevant clinical endpoints such as progression unengaged survival in patients with MRCC.
Following evaluation of clinical text submitted by the marketing authorisation holder, the Committee recommended a swap from the conditional marketing authorisation to a buxom marketing authorisation. It also recommended to extend the clues to blue ribbon-stripe treatment of advanced and/or metastatic renal cell carcinoma (MRCC).
Extension of forewarning
In reckoning to the extension of indication for Sutent, the Committee gave pragmatical opinions championing applications for extensions of indication, adding up to date treatment options for the following at one time approved medicines:
– Aldara (imiquimod), from Laboratoires 3M Santé, received a satisfied conviction to catalogue superficial treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratosis in adults. Aldara was essential granted a marketing authorisation in the European Conjunction on 18 September 1998 and is currently indicated for the up to date treatment of external genital and perianal warts and miserly superficial basal cell carcinomas in adults.
– Glivec (imatinib mesylate), from Novartis Europharm Ltd, received two positive opinions to subsume treatment of myelodysplastic syndromes and myeloproliferative diseases (MDS/MPD) as indeed as treatment of of age patients with hypereosinophilic syndrome and inveterate eosinophilic leukaemia (HES/CEL). Glivec was first granted a marketing authorisation in the European Union on 7 November 2001 and is currently indicated for the treatment of adult and paediatric patients with Philadelphia chromosome (bcr-abl) positive dyed in the wool myeloid leukaemia, adult patients with Philadelphia chromosome pontifical acute lymphoblastic leukaemia (Ph+ ALL), adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) and full-grown patients with dermatofibrosarcoma protuberans (DFSP).
– Hycamtin (topotecan), from SmithKline Beecham Plc, received a positive opinion to include treatment, in combination with cisplatin, of patients with carcinoma of the cervix regular after radiotherapy and for patients with Stage IVB disease. Patients with until revealing to cisplatin make a incessant treatment-unbind interval to justify treatment with the combination. Hycamtin was first granted a marketing authorisation in the European Union on 12 November 1996 and is currently indicated as monotherapy for relocate-line treatment of patients with metastatic carcinoma of the ovary and patients with relapsed small-scale apartment lung cancer.
– Rotarix (live Good Samaritan rotavirus RIX4414), an word-of-mouth vaccine from GlaxoSmithKline Biologicals, received a sure opinion to extend the therapeutic indication to categorize stylish information that shelter against rotavirus serotypes G4P[8] and G22P[4] has also been demonstrated. Rotarix was first granted a marketing authorisation in the European Union on 21 February 2001 and indicated due to the fact that the prevention of gastro-enteritis caused by Rotavirus of types G1P[8], G3P[8] and G9P[8].
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New contraindications
The Committee recommended adding new contraindications for four medicinal products that stifle duloxetine as active substance. With a view all four products, namely Ariclaim and Xeristar, from Boehringer Ingelheim International GmbH, and Yentreve and Cymbalta, from Eli Lilly Nederland, the Committee recommended that treatment should not be initiated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis.
In joining, as a replacement for Ariclaim and Yentreve, the Board also recommended that these two products should not be used in patients with plain renal enfeeblement. This contraindication is already included in the offshoot poop for Cymbalta and Xeristar.
Ariclaim and Yentreve were first granted marketing authorisations on 11 August 2004 and are currently authorised since the treatment of unexcessive to severe stress urinary incontinence in women. Cymbalta and Xeristar were word go granted marketing authorisations on 17 December 2004 and are currently authorised for the treatment of major depressive episodes and the treatment of diabetic unimportant neuropathic pain in adults.
Summaries of opinions, including more complicated message on the further indications or contraindications for all products mentioned above are at and can be found here www.emea.europa.eu/htms/human/opinion/opinion.htm.
Referral procedures concluded
The Committee concluded a referral procedure for Alendros 70 (alendronate sodium trihydricum), from Zentiva a.s., intended for the treatment of osteoporosis in postmenopausal women. The CHMP recommended the refusal of a marketing authorisation in the troubled Associate States and a expulsion of the marketing authorisation for Alendros 70 mg tablets in the reference Associate State because bioequivalence with the reference product (Fosamax 70 mg tablets) has not been demonstrated. The forth was initiated under Article 29 of the Community code on human medicinal products (Directive 2001/83/EC as amended) by the Czech Republic because of disagreement among the Member States in the structure of the mutual recognition procedure.
The Body concluded a referral procedure recommending the suspension of a generic medicinal product called Simvastatine (simvastatine), from Neo Pharma Ltd, because of non-compliance with tolerable clinical vocation (GCP) in the lead of the lucubrate utilized to demonstrate bioequivalence with the originator upshot. The procedure was initiated by the Netherlands under Article 36 of the Community unwritten law’ on human therapeutic products (Directive 2001/83/EC as amended). These procedures are initiated where a Member State considers that there are public health concerns relating to a consequence that may require regulatory action in all Member States where the artifact is authorised.
Referral procedures started
The Board started referral procedures respecting two generic medicinal products included Article 29 of the Community code on woman medicinal products (Directive 2001/83/EC as amended) because of disagreement surrounded by the Member States in the structure of the mutual recognition forge ahead:
– The referral for Cefuroximaxetil 125 omhulde tabletten 125 mg, Cefuroximaxetil 250 omhulde tabletten 250 mg, Cefuroximaxetil 500 omhulde tabletten 500 mg, (cefuroxim (as axetil)), from Sandoz B.V., was initiated because of disagreements on whether the medicinal effect should be indicated for the treatment of uncomplicated gonorrhoea (urethritis and cervicitis).
– The referral for Fexofenadinhydrochlorid “Teva” 120 mg and 180 mg film-coated tablets (fexofenadine hydrochloride), from Teva UK Ltd, was initiated because of disagreements concerning bioequivalence with the originator product.
A more detailed CHMP meeting scrutinize purposefulness be published shortly.
http://www.emea.europa.eu
Watch numb information on Aldara; Cymbalta; Elaprase.