FDA pipeline preview, September 2007


The latest FDA action (through September 2007) related to satraplatin, ropinirole (Requip CR), sumatriptan/naproxen (Trexima,) desvenlafaxine (Pristiq), eprodisate (Kiacta,) raloxifene (Evista), natalizumab (Tysabri), bifeprunox, fluticasone/salmeterol inhalation powder (Advair Diskus 500/50), LX211, TZP-101, Alferminogene tadenovec, Ad5FGF-4 (Generx), tramiprosate (Alzhemed), rilonacept, aripiprazole (Abilify), sapropterin (Kuvan), oral topotecan (Hycamtin), mifepristone (Corlux), vitiligo-derived IgG (VitiGam)

Key Points

NDA withdrawn

• Satraplatin (GPC Biotech) for the treatment of hormone-refractory prostate cancer in patients whose prior chemotherapy has failed

Approvable designations

• Sumatriptan/naproxen (Trexima, Pozen/GlaxoSmithKline) for the acute treatment of migraine headaches (second approvable letter)

• Desvenlafaxine (Pristiq, Wyeth) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause

• Eprodisate (Kiacta, Neurochem) for the treatment of amyloid A (AA) amyloidosis (second approvable letter)

Recommendations for approval

• Raloxifene (Evista, Eli Lilly) for the reduction of invasive breast cancer risk in postmenopausal women with osteoporosis and in postmenopausal women at high risk for breast cancer

• Natalizumab (Tysabri, Elan/ Biogen Idec) for the treatment of moderate-to-severe Crohn's disease in patients who have failed or cannot tolerate available therapies

Nonapprovable designations

• Bifeprunox (Wyeth/Solvay) for the acute treatment of schizophrenia and maintenance of stable adult patients

• Fluticasone/salmeterol inhalation powder (Advair Diskus 500/50, GlaxoSmithKline) for the treatment of stage IIB to stage IV metastatic melanoma

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