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EU backs Pfizer HIV drug Maraviroc facing U.S. delay
  Thu Jul 19, 2007 9:56 PM BST162
NEW YORK, July 19 (Reuters) - The scientific committee of the European Medicines Agency said on Friday it had recommended approval of Pfizer Inc.'s (PFE.N: Quote, Profile , Research) Celsentri, a new type of treatment for HIV whose approval has been delayed in the United States.
The Committee for Medicinal Products (CHMP) said it had recommended marketing approval of Celsentri, known as maraviroc in the United States, for use with other anti-HIV drugs among adult patients infected with the HIV-1 strain of the virus.
But the committee said Celsentri is meant to be used only among CCR5-tropic patients, meaning those whose HIV virus uses the CCR5 co-receptor as a portal into human cells.
Pfizer last month received a so-called approvable letter from the U.S. Food and Drug Administration for its twice-a-day maraviroc pill, the first drug designed to keep the HIV virus that causes AIDS from entering healthy cells of the immune system. Older HIV medicines attack the virus itself.
Pfizer said the FDA would approve maraviroc once certain conditions were met, but it did not specify the requirements.
The Committee for Medicinal Products on Friday said it had also recommended approval in Europe of Pfizer's Ecalta (anidulafungin) as a treatment for invasive candidiasis in adult patients who have normal levels of infection-fighting immune system cells called neutrophils.
Invasive candidiasis is an infection that occurs when the Candida species of fungus enters the bloodstream, where it can then spread througout the body. People at greatest risk of the fungal condition are low-birthweight babies, surgery patients and those with immune deficiencies.
Recommendations for marketing approval by the Committee for Medicinal Products are normally endorsed by the European Commission within a few months.
(Reporting by Ransdell Pierson in New York, Jonathan Cable in London)
LONDON, July 19, 2007-On 19 July 2007 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,?? recommending to grant a marketing authorisation for the medicinal product Celsentri, 150 mg & 300 mg, film-coated tablet intended for treatment of Human Immunodeficiency Virus (HIV-1) infected adult patients, who are treatment-experienced and have only CCR5-tropic HIV-1 detectable. The applicant for this medicinal product is Pfizer Limited.
The active substance of CELSENTRI is maraviroc, a CCR5 inhibitor (ATC Code: J05AX09). It selectively binds to the human chemokine receptor CCR5, preventing CCR5-tropic HIV-1 from entering cells.
The benefits with CELSENTRI when used in combination with other antiretroviral medicinal products are its ability to reduce the amount of HIV in plasma (viral load) and to increase the number of T cells (specifically CD4 cells) in the treatment of heavily experienced patients with CCR5-tropic HIV-1. This was shown in two double-blind, randomized studies comparing maraviroc 300 mg QD versus maraviroc 300 mg BID versus placebo, all in combination with optimized background therapy. At week 48, maraviroc was superior to placebo with regard to the proportion of patients with undetectable viral load. The most common side effects are diarrhoea, nausea and headache; the dose limiting adverse event is postural hypotension. Since maraviroc may potentially have a negative impact on immune function due to the mechanism of action, this potential risk has been identified as an issue for follow-up.
A pharmacovigilance plan for CELSENTRI, as for all medicinal products, will be implemented as part of the marketing authorisation.
The approved indication is: "CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable (see section 4.2). This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials in treatment-experienced patients (see section 5.1)." Therapy with CELSENTRI should be initiated by a physician experienced in the management of HIV infection.
Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC) which will be published in the European Public Assessment Report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit to risk balance for CELSENTRI and therefore recommends the granting of the marketing authorisation.
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