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

July 1, 2011

Recent FDA action (through June 2011) related to oxycodone, aflibercept opthalmic solution, icatibant, eculizumab, asimadoline, anthrax vaccine, SBC-102 enzyme replacement therapy, ciprofloxacin, mitosol, MORAb-004 and MORAb-066, levofloxacin.

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.