FDA Pipeline preview, April 2008

Recent FDA action (through April 2008) related to Rotavirus vaccine, live, oral; istradefylline; olanzapine long-acting injection; mycobacterial cell wall-DNA complex; talactoferrin; levodopa/carbidopa intestinal gel; prasugrel; eltrombopag; difluprednate ophthalmic emulsion; EUR-1008; ARG201; MGCD0103; triphendiol; ADH-1; and levofloxacin solution for inhalation.

Recommended for approval

• Rotavirus vaccine, live, oral (Rotarix, GlaxoSmithKline) to prevent rotavirus gastroenteritis in infants

Nonapprovable designations

• Olanzapine long-acting injection (Zyprexa, Eli Lilly) for the treatment and maintenance therapy of schizophrenia in adult patients

Fast-track designations

• Mycobacterial cell wall-DNA complex (Urocidin, Bioniche Life Sciences) for the first-line treatment of non-muscle-invasive bladder cancer

• Talactoferrin (Agennix) as monotherapy for the treatment of patients with non-small cell lung cancer (NSCLC) in whom ≥2 previous therapies have failed

• Levodopa/carbidopa intestinal gel (Duodopa, Solvay) for the long-term treatment of motor fluctuations associated with advanced PD

Priority review

• Prasugrel (Daiichi Sankyo/Eli Lilly) for the treatment of acute coronary syndrome (ACS) in patients undergoing percutaneous coronary intervention (PCI)

• Eltrombopag (Promacta, GlaxoSmithKline) for the short-term treatment of chronic idiopathic thrombocytopenic purpura (ITP)

• Difluprednate ophthalmic emulsion (Durezol, Sirion) for the treatment of postoperative ocular inflammation

• EUR-1008 (Zentase, Eurand) for the treatment of pancreatic insufficiency

Orphan drug designations

• ARG201 (arGentis) for the treatment of diffuse systemic sclerosis (systemic scleroderma)

• MGCD0103 (Pharmion/MethylGene) for the treatment of acute myelogenous leukemia (AML)

• Triphendiol (Marshall Edwards) for the treatment of stage IIB through stage IV malignant melanoma

• ADH-1 (Adherex Technologies) in combination with melphalan for the treatment of stage IIB/C, III, and IV malignant melanoma

• Levofloxacin solution for inhalation (Mpex) for the treatment of pulmonary infections caused by Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis