FDA Pipeline Preview, July 2011 (Pfizer, Pain Therapeutics, Regeneron Pharmaceuticals, Alexion, Tioga Pharmaceuticals, Emergent BioSolutions, Synageva BioPharma, Aradigm, Mobius Therapeutics, Morphotek)

Complete response

• Oxycodone (Remoxy, Pfizer and Pain Therapeutics) extended-release capsules CII for the relief of moderate-to-severe pain requiring continuous, around-the-clock opioid treatment.

Recommended for approval

• Icatibant (Firazyr, Shire) for the treatment of acute attacks of hereditary angioedema in patients aged 18 years and older.

Priority review

• Eculizumab (Soliris, Alexion) for the treatment of atypical hemolytic uremic syndrome.

Fast-track designations

• Asimadoline (Tioga Pharmaceuticals) for the treatment of irritable bowel syndrome.

• Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant (NuThrax, Emergent BioSolutions) for the treatment of anthrax.

• SBC-102 enzyme replacement therapy (Synageva BioPharma) for the treatment of lysosomal acid lipase deficiency.

Orphan drug designations

• Ciprofloxacin for inhalation (Aradigm) for the management of bronchiectasis.

• Mitosol (Mobius Therapeutics) for the prevention of corneal haze following surface ablation laser keratectomy.

• MORAb-004 and MORAb-066 (Morphotek) for the treatment of soft-tissue sarcoma and pancreatic cancer, respectively.