Pipeline Preview, January 2008


FDA-related information through January 2008 on Extended-release ropinirole (Requip XL); Indiplon; Xience V Everolimus Eluting Coronary Stent System; tetrabenazine; vernakalant (Kynapid); gepirone extended-release; lovastatin (Mevacor); bevacizumab (Avastin); tedisamil; rabies monoclonal antibody cocktail; AVI-4658; alfimeprase; Prochymal; aripiprazole (Abilify); bendamustine (Treanda); ATIR; CDX-110; and ISIS 333611

Key Points

Approvable designations

• Extended-release formulation of ropinirole (Requip XL, SkyePharma/GlaxoSmithKline) for the treatment of the signs and symptoms of idiopathic Parkinson disease (PD)

• Indiplon (Neurocrine Biosciences) for the treatment of insomnia (second approvable letter)

• A drug-eluting stent (Xience V Everolimus Eluting Coronary Stent System, Abbott) for the treatment of coronary artery disease

• Tetrabenazine (Prestwick) for the treatment of chorea associated with Huntington disease

• Vernakalant (Kynapid, Cardiome/ Astellas) for the rapid conversion of acute atrial fibrillation (AF) to sinus rhythm

Nonapprovable designation

• Gepirone extended-release (Fabre-Kramer/GlaxoSmithKline) for the treatment of adults with major depressive disorder (second nonapprovable letter)

Not recommended for approval

• Lovastatin (Mevacor, Merck) for over-the-counter (OTC) use for the treatment of elevated cholesterol levels as an adjunct to diet and to reduce the risk of myocardial infarction (MI), unstable angina, and coronary revascularization procedures in patients with average or moderately elevated cholesterol levels

• Bevacizumab (Avastin, Genentech) in combination with paclitaxel for the treatment of patients who have not received chemotherapy for locally recurrent or metastatic HER2-negative breast cancer

• Tedisamil (Solvay) for the rapid conversion of recent-onset AF to normal sinus rhythm

Fast-track designations

• Rabies monoclonal antibody cocktail (Crucell) for the postexposure prophylaxis of rabies

• AVI-4658 (AVI BioPharma) for the treatment of Duchenne muscular dystrophy

• Alfimeprase (Nuvelo) for the treatment of acute ischemic stroke

• Preparation of mesenchymal stem cells (Prochymal, Osiris) for the first-line treatment of acute graft-versus-host disease

Priority review

• Aripiprazole (Abilify, Otsuka/ Bristol-Myers Squibb) for the treatment of pediatric patients (aged 10–17 y) with bipolar I disorder

• Bendamustine (Treanda, Cephalon) for the first-line treatment of chronic lymphocytic leukemia

Orphan drug designations

• ATIR (Kiadis) for immune reconstitution and prevention of graft-versus-host disease following allogeneic bone marrow transplantation

• CDX-110 (Celldex) for the treatment of EGFRvIII-expressing glioblastoma multiforme

• ISIS 333611 (Isis) for the treatment of an inherited form of amyotrophic lateral sclerosis (ALS)

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