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NDA withdrawn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
Employers Face Barriers With Adopting Biosimilars
March 1st 2022Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
