FDA Pipeline Preview, November 2010 (Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor)

Recent FDA action (through, October 2010) related to Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor.

Complete response

• Phentermine/topiramate (Qnexa, Vivus) controlled-release capsules for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with comorbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity.

• Human insulin [rDNA origin] (Linjeta, Biodel) injection 100 IU/mL for the treatment of type 1 and type 2 diabetes mellitus
to improve glycemic control.

• Exenatide extended-release for injectable suspension (Bydureon, Amylin, Lilly, and Alkermes) for the once-weekly treatment of type 2 diabetes.

• Albinterferon alfa-2b (Zalbin, Human Genome Sciences and Novartis) 900 µg for the treatment of chronic hepatitis C. HGS and Novartis have decided not to develop this drug further.

• AZ-004 (Staccato loxapine, Alexza Pharmaceuticals), submitted as Adasuve Staccato (loxapine) inhalation aerosol, 5 mg and 10 mg, for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

• Tapentadol extended-release oral analgesic (Johnson & Johnson) tablets for the treatment of moderate to severe chronic pain in patients aged 18 years or older.

Fast-track designations

• AVP-21D9 (Emergent BioSolutions) for the treatment of inhalational anthrax.

• 1% tenofovir vaginal gel (Conrad, a division of the Eastern Virginia Medical School) for the prevention of HIV and herpes infection in women.

Orphan drug designations

• AFM 13 (Affimed Therapeutics) for the treatment of Hodgkin lymphoma.

• hGH-CTP (Prolor Biotech) for the treatment of growth hormone deficiency in adults and children.

• Rozrolimupab (Sym001) (Symphogen and Swedish Orphan Biovitrum) for the treatment of primary immune thrombocytopenia.

• Nefecon (PL-56) (Pharmalink AB) for the treatment of IgA nephropathy, or Berger's Disease.

• SB518 JAK2 inhibitor (S*BIO) for the treatment of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF).