Following a 15-year high in 2012, new FDA drug approvals were down last year.
Among the 27 new drugs approved in 2013 were eight new cancer therapies, three diagnostic imaging agents and three medicines that received expedited review under the FDA’s new “breakthrough therapy” designation program.
That’s about on par with the average over the past five years (28), Reuters reported. Fewer new drug applications were filed this year overall, Reuters said; last year, the agency received 41 applications and gave the green light to 39 new therapies.
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Enacted in the summer of 2012, the breakthrough therapy pathway yielded its first fruits in Q4 2013 in the form of Gazyva, a lymphocytic leukemia drug developed by Roche, Johnson & Johnson’s lymphoma drug Imbruvica and Gilead Science’s Sovaldi for hepatitis C.
The pathway gives expedited review to products that show early promise in treating serious or life-threatening conditions better than existing treatment options. Drugmakers have applauded the program, saying it makes the approval process much smoother and faster. But the agency only granted a third of the requests it received for breakthrough therapy designation it FY13.
Here’s the complete list of approved drugs, the companies that market them and their indications:
- Anoro Ellipta (GlaxoSmithKline, COPD)
- Sovaldi (Gilead Sciences, hepatitis C)
- Olysio (Janssen Pharmaceuticals, hepatitis C)
- Luzu (Valeant Pharmaceuticals, athletes foot, jock itch and ringworm)
- Imbruvica (Pharmacyclics, mantle cell lymphoma)
- Aptiom (Sunovion Pharmaceuticals, epilepsy)
- Gazyva (Genentech, lymphocytic leukemia)
- Vizamyl (GE Healthcare, radioactive agent for PET imaging for Alzheimer’s disease)
- Opsumit (Actelion Pharmaceuticals, hypertension)
- Adempas (Bayer Healthcare, hypertension)
- Duavee (Pfizer, menopausal hot flashes)
- Brintellix (Lundbeck, depression)
- Tivicay (ViiV Healthcare, HIV)
- Gilotrif (Boehringer Ingelheim Pharmaceuticals, metastatic non-small-cell lung cancer)
- Mekinist (GlaxoSmithKline, melanoma)
- Tafinlar (GlaxoSmithKline, melanoma)
- Xofigo (Bayer Pharmaceuticals, prostate cancer)
- Breo Ellipta (GlaxoSmithKline, COPD)
- Invokana (Johnson & Johnson, type 2 diabetes)
- Tecfidera (Biogen Idec, multiple sclerosis)
- Dotarem (Guerbet, imaging agent for MRI)
- Lymphoseek (Navidea Biopharmaceuticals, imaging agent for cancer diagnosis)
- Osphena (Shionogi, dyspareunia due to menopause)
- Kadcyla (Genentech, HER2-positive breast cancer)
- Pomalyst (Celgene, multiple myeloma)
- Kynamro (Genzyme, high cholesterol)
- Nesina (Takeda, type 2 diabetes)
