Recent FDA action (through January 2010) related to testosterone undecanoate injection, telavancin, Ampligen, doxepin, everolimus, aztreonam lysine, erlotinib, TG4010, BSI-201, midazolam, Aimspro, Motorgraft, BHR-100, dextran sulfate
Complete response
• Extended-duration testosterone undecanoate injection (Aveed, Endo Pharmaceuticals Holdings) for men diagnosed with low testosterone.
• Telavancin (Vibativ, Theravance) for the treatment of nosocomial pneumonia.
• Doxepin (Silenor, Somaxon Pharmaceuticals) for the treatment of insomnia.
Recommended for approval
• Everolimus (Novartis) for the prophylaxis of acute organ rejection in de novo kidney transplant recipients.
• Inhalable aztreonam lysine (Cayston, Gilead) for the treatment of lung infection caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
Not recommended for approval
• Erlotinib (Tarceva, OSI Pharmaceuticals and Roche's Genentech unit) for the treatment of advanced lung cancer.
Fast track designation
• TG4010 (Transgene) for the first-line treatment of advanced non-small cell lung cancer in combination with chemotherapy.
• BSI-201 (Sanofi-aventis, BiPar Sciences unit) combined with chemotherapy for the treament of breast cancer in patients with metastatic triple-negative breast cancer.
Orphan drug designation
• Midazolam (Ikano Therapeutics) for the acute treatment of certain forms of epileptic seizure known as cluster seizures or alternatively, as acute repetitive seizures.
• Anti-inflammatory agent (Aimspro, Daval International) for the treatment of amyotrophic lateral sclerosis.
• Stem cell-derived motor neuron product (Motorgraft, California Stem Cell) for the treatment of spinal muscular atrophy.
• BHR-100 (Progesterone, BHR Pharma) for treatment of traumatic brain injury.
• Low molecular weight dextran sulfate (IBsolvMIR, TikoMed) for preventing the rejection of transplanted pancreatic islet cells in type 1 patients.
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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