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).
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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