recommendations for fda approval

Inpharma 1070 - 18 Jan 1997 Recommendations for FDA approval A US FDA advisory panel has voted 6 to 1 to recommend 2 versions of the recombinant human growth hormone, somatropin [‘Nutropin’; Genentech and ‘Humatrope’; Eli Lilly] for approval to treat very short stature associated with Turner’s Syndrome, reports Bioworld Today. 1 Eli Lilly and Genentech pooled clinical trial results from 4 clinical trials to convince the FDA advisory panel. The Genetic Institute’s recombinant Factor IX product [‘Benefix’] was unanimously recommended for approval by an FDA advisory panel for the treatment of haemophilia B. 2 This is an extremely rare bleeding disorder that affects around 3000, mainly male, Americans. Organon Teknika Corporation’s BCG (Bacillus Calmette Gu´ erin) preparation [‘TICE’] has been recommended for approval to treat recurrent papillary bladder cancer, reports Bioworld Today. 3 Although BCG is used in many countries as tuberculosis prophylaxis, it has not been approved for this use in the US. Ciba Geigy’s letrozole [‘Femara’] was recommended for approval by an FDA advisory committee for the treatment of advanced breast cancer . 4 The recommendation was based on a trend towards a superior response rate compared with megestrol in a recent phase II clinical trial, reports the Pink Sheet. Troglitazone has received a unanimous recommendation for approval from a US FDA advisory committee, reports Marketletter. 5 Troglitazone [‘Rezulin’; Warner-Lambert] is a thiazolidinedione and is recommended for use in patients with non-insulin- dependent diabetes mellitus (NIDDM) who have poor glucose control despite treatment with insulin and at least 1 oral hypoglycaemic agent. 1. Seachrist L. Advisory panel recommends Nutropin, Humatrope for Turner’s syndrome. Bioworld Today 7: 1-2, 12 Dec 1996. 2. Seachrist L. FDA Panel recommends recombinant clotting factor. Bioworld Today 7: 1&4, 13 Dec 1996. 3. Seachrist L. FDA Panel recommends expanding BCG’s role in treating bladder cancer. Bioworld Today 7: 1-2, 17 Dec 1996. 4. Ciba-Geigy Femara advanced breast cancer approval recommendation based on response rate data; CMTE. splits over requiring tamoxifen washout for trials. FDC Reports - Pink Sheet - Prescription Pharmaceuticals and Biotechnology 58: 20, 23 Dec 1996. 5. W-L’s diabetes drug backed for US approval. Marketletter [Copy 2] 23: 19, 23 Dec 1996. 800458320 1 Inpharma 18 Jan 1997 No. 1070 1173-8324/10/1070-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1070 - 18 Jan 1997

Recommendations for FDAapproval

A US FDA advisory panel has voted 6 to 1 torecommend 2 versions of the recombinant humangrowth hormone, somatropin [‘Nutropin’; Genentechand ‘Humatrope’; Eli Lilly] for approval to treat veryshort stature associated with Turner’s Syndrome,reports Bioworld Today.1 Eli Lilly and Genentech pooledclinical trial results from 4 clinical trials to convince theFDA advisory panel.

The Genetic Institute’s recombinant Factor IX product[‘Benefix’] was unanimously recommended for approvalby an FDA advisory panel for the treatment ofhaemophilia B.2 This is an extremely rare bleedingdisorder that affects around 3000, mainly male,Americans.

Organon Teknika Corporation’s BCG (BacillusCalmette Guerin) preparation [‘TICE’] has beenrecommended for approval to treat recurrent papillarybladder cancer, reports Bioworld Today. 3 Although BCGis used in many countries as tuberculosis prophylaxis, ithas not been approved for this use in the US.

Ciba Geigy’s letrozole [‘Femara’] was recommendedfor approval by an FDA advisory committee for thetreatment of advanced breast cancer .4 Therecommendation was based on a trend towards asuperior response rate compared with megestrol in arecent phase II clinical trial, reports the Pink Sheet.

Troglitazone has received a unanimousrecommendation for approval from a US FDA advisorycommittee, reports Marketletter.5 Troglitazone[‘Rezulin’; Warner-Lambert] is a thiazolidinedione and isrecommended for use in patients with non-insulin-dependent diabetes mellitus (NIDDM) who have poorglucose control despite treatment with insulin and atleast 1 oral hypoglycaemic agent.1. Seachrist L. Advisory panel recommends Nutropin, Humatrope for Turner’s

syndrome. Bioworld Today 7: 1-2, 12 Dec 1996.2. Seachrist L. FDA Panel recommends recombinant clotting factor. Bioworld

Today 7: 1&4, 13 Dec 1996.3. Seachrist L. FDA Panel recommends expanding BCG’s role in treating bladder

cancer. Bioworld Today 7: 1-2, 17 Dec 1996.4. Ciba-Geigy Femara advanced breast cancer approval recommendation based on

response rate data; CMTE. splits over requiring tamoxifen washout for trials.FDC Reports - Pink Sheet - Prescription Pharmaceuticals and Biotechnology 58:20, 23 Dec 1996.

5. W-L’s diabetes drug backed for US approval. Marketletter [Copy 2] 23: 19, 23Dec 1996.

800458320

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