Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

Since the US Food and Drug Administration’s breakthrough therapy designation (BTD) was put into effect in July of 2012, pharma and biotech companies have certainly taken note, according to the new report, titled Breakthrough Therapy Designation: A Breakthrough Year for Unmet Diseases, from EP Vantage, the editorial arm of Evaluate.

The FDA data indicate that no fewer than 141 BTDs have been applied for, of which 37 have been granted. Thus far, three breakthrough-designated products have received US approval: Roche's (ROG: SIX) Gazyva (obinutuzumab), Johnson & Johnson (NYSE: JNJ)/Pharmacyclics' (Nasdaq: PCYC) Imbruvica (ibrutinib) and Gilead Sciences' (Nasdaq: GILD) Sovaldi (sofosbuvir).