Meeting Highlights From CHMP, 19-22 February 2007 - Second Mock-up Pandemic Influenza Vaccine Receives Positive Opinion - Europe

Main Category: Bird Flu / Avian Flu
Also Included In: Flu / Cold / SARS;  Respiratory / Asthma;  Pharma Industry / Biotech Industry
Article Date: 23 Feb 2007 - 6:00 PDT

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The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation for Focetria, from Novartis Vaccines and Diagnostics S.r.l. Focetria is a mock-up pandemic influenza vaccine, intended for the prevention of influenza during an officially declared pandemic situation, once the pandemic viral strain has been included. It is the second mock-up pandemic influenza vaccine to receive a positive opinion from the Committee. EMEA review began on 31 January 2006 with an active review time of 162 days.

Mock-up pandemic influenza vaccines are approved only for use in a declared pandemic influenza situation. The objective is to have a marketing authorisation in place that can be changed quickly in the event of a pandemic to include the virus strain responsible, once it has been identified.

A detailed question and answer document on mock-up pandemic influenza vaccines was published in December 2006 and is available here.

Other initial marketing authorisation applications
The CHMP adopted positive opinions for:

-- Advagraf (tacrolimus), from Astellas Pharma GmbH, intended for prevention and treatment of transplant rejection. EMEA review began on 1 March 2006, with an active review time of 201 days.

-- Sebivo (telbivudine), from Novartis Europharm Limited, intended for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and active liver inflammation. EMEA review began on 1 March 2006, with an active review time of 210 days.

-- Toviaz (fesoterodine), from Schwarz Pharma, intended for the symptomatic treatment of overactive bladder syndrome. EMEA review began on 29 March 2006, with an active review time of 210 days. Extensions of indication The Committee gave positive opinions for applications for extensions of indication, adding new treatment options for the following previously approved medicines:

-- Avastin (bevacizumab), from Roche Registration Ltd, to extend the indication to include Avastin in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer. Avastin was first authorised in the European Union on 12 January 2005 and is currently authorised for the treatment of patients with metastatic carcinoma of the colon or rectum.

-- Xeloda (capecitabine), from Roche Registration Ltd, to extend the indication to include first-line treatment of patients with advanced gastric cancer in combination with a platinum-based regimen. Xeloda was first authorised in the European Union on 19 October 2000 and is currently authorised for the treatment of patients with colon cancer, metastatic colorectal cancer and locally advanced or metastatic breast cancer.

-- Prevenar (pneumococcal conjugate vaccine), from Wyeth-Lederle Vaccines S.A., to extend the indication from active immunisation against bacteraemic pneumonia to active immunisation against pneumonia caused by streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23. Prevenar was first granted a marketing authorisation in the European Union on 2 February 2001 and is currently approved for active immunisation of children from 2 months to 5 years of age against sepsis, meningitis, bacteraemic pneumonia and bacteraemia caused by the same serotypes.

Summaries of all mentioned opinions, including more detailed information on the new indications for all products mentioned above are available and can be found here.

Referral procedures concluded

The Committee concluded a harmonisation referral under Article 30 of the Community code on human medicinal products (Directive 83/2001/EC as amended) for Xefo (lornoxicam) and associated names, recommending to harmonise the product information across the EU. Xefo is approved in a number of EU Member States for the relief of pain. The procedure was initiated at the request of the marketing authorisation holder, Nycomed Danmark ApS. Article 30 referrals are initiated with a view to harmonising product information for medicinal products authorised at Member State level.

Referral procedures started

The Committee started a referral procedure for Vantas 50 mg implant (histrelin acetate), from Valera Pharmaceuticals Ltd, Ireland. The procedure was initiated under Article 29 of Directive 2001/83/EC as amended because of disagreement between the Member States in the context of the mutual recognition procedure regarding the safety and efficacy of the medicinal product. Vantas is intended for the treatment of advanced prostate cancer.

Referral procedure re-examined

The Committee concluded the re-examination of its opinion on the referral procedure for Alendros 70 (alendronate sodium trihydricum), from Zentiva a.s. Alendros 70 was intended for the treatment of osteoporosis in postmenopausal women. The CHMP confirmed its previous position and recommended the refusal of a marketing authorisation in the concerned Member States and a suspension of the marketing authorisation for Alendros 70 mg tablets in the reference Member State because bioequivalence with the reference product (Fosamax 70 mg tablets) has not been demonstrated. The procedure 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 context of the mutual recognition procedure.

A more detailed CHMP meeting report will be published shortly.

http://www.emea.europa.eu

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