cpmp recommendations for approval

22 MARKET NEWS CPMP recommendations for approval The Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency has recommended that fomivirsen ['Vitravene'; Isis, CIBA Vision] be approved. I Fomivirsen, an antisense inhibitor, is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. Specifically, fomivirsen will be used for the local treatment of newly-diagnosed or advanced CMV retinitis that has not responded to other treatments or where other treatments are not suitable. The treatment was launched in the US late last year. * The CPMP has also recommended the approval of follitropin alfa ['Gonal-F'; Ares-Serono] in a new indication, the treatment of a type of male infertility (hypogonadotrophic hypogonadism), reports Scrip.2 If approved, follitropin alfa will be the first recombinant follicle stimulating hormone to be approved for this type of male infertility in the European Union. The CPMP has also recommended that a new strength of follitropin alfa be approved - 37 .5IU. • See Inpharma 1163: 22, I4 Nov 1998; 800632405 1. Isis Pharmaceuticals Inc. Isis and CIBA VlSion announce European CPMP recommends approval of Vitravcne for patients with both newly diagnosed and advanced CMV retinitis. Media Release: [2 pages). 28 Apr 1999 2. Semno's Gona\.p for male infertility. Scrip 2428: 27, 14 Apr 1999 IOOW77S Inphanne- 8 May 1999 No. 1186 1173-8324199/1186-000221$01.00«' Adlalntamatlonal Limited 1999. All rights reserved

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Page 1: CPMP recommendations for approval

22 MARKET NEWS CPMP recommendations for approval

The Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency has recommended that fomivirsen ['Vitravene'; Isis, CIBA Vision] be approved. I

Fomivirsen, an antisense inhibitor, is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. Specifically, fomivirsen will be used for the local treatment of newly-diagnosed or advanced CMV retinitis that has not responded to other treatments or where other treatments are not suitable.

The treatment was launched in the US late last year. *

The CPMP has also recommended the approval of follitropin alfa ['Gonal-F'; Ares-Serono] in a new indication, the treatment of a type of male infertility (hypogonadotrophic hypogonadism), reports Scrip.2

If approved, follitropin alfa will be the first recombinant follicle stimulating hormone to be approved for this type of male infertility in the European Union.

The CPMP has also recommended that a new strength of follitropin alfa be approved - 37 .5IU. • See Inpharma 1163: 22, I4 Nov 1998; 800632405 1. Isis Pharmaceuticals Inc. Isis and CIBA VlSion announce European CPMP recommends approval of Vitravcne for patients with both newly diagnosed and

advanced CMV retinitis. Media Release: [2 pages). 28 Apr 1999 2. Semno's Gona\.p for male infertility. Scrip 2428: 27, 14 Apr 1999 IOOW77S

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