FDA pipeline preview, August 2007

Key Points

NDA withdrawn

• Rimonabant (Zimulti , Sanofi-Aventis) for weight management in obese and overweight patients with associated risk factors

Approvable designations

• Risperidone (Risperdal, Janssen) for the treatment of schizophrenia in adolescents aged 13 to 17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents aged 10 to 17 years

• Maraviroc (Pfizer) as therapy for treatment-experienced patients infected with CCR5-tropic HIV-1

• Sitaxsentan (Thelin, Encysive) for the treatment of pulmonary arterial hypertension (PAH) (third approvable letter)

Fast-track designation

• HCV-796 (ViroPharma) for the treatment of hepatitis C virus (HCV) infection

Priority review

• Docetaxel (Taxotere Injection Concentrate, Sanofi-Aventis) in combination with cisplatin and fluorouracil for induction (neoadjuvant) therapy of patients with locally advanced squamous cell carcinoma of the head and neck prior to chemoradiotherapy and surgery

• Raltegravir (Isentress, Merck) in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy

• Topotecan (Hycamtin, GlaxoSmithKline) for the treatment of relapsed small cell lung cancer (SCLC)

• Ixabepilone (Bristol-Myers Squibb) as monotherapy for the treatment of metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine and in combination with capecitabine for the treatment of metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane

• Cetuximab (Erbitux, ImClone Systems) for the treatment of patients with EGFR-expressing metastatic colorectal cancer whose disease has progressed following, or who were not candidates to receive, irinotecan- or oxaliplatin-based chemotherapy

Orphan drug designations

• Leukocyte interleukin (Multikine, CEL-SCI) as neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck

• Pafuramidine (Immtech) for the treatment of malaria

Orphan drug designation revocation

• ALTU-135 (Altus) for the treatment of pancreatic insufficiency