- Since breakthrough therapy designations were introduced in 2012, large pharma companies have benefited more than other companies, according to a new report from EP Vantage.
- Between July 2012 and June 2016, only 6 of 31 approved drugs that had been granted the status were developed by small companies and biotechs. Drugs tagged with a breakthrough designation (BTD) and developed by big pharma companies also had shorter average review and approval times than those from smaller counterparts, according to the analysis.
- Based on the data from the report, BioPharma Dive also found that 48% of approved drugs with a BTD were in oncology, while designated hepatitis C and fibrosis drugs accounted 16% and 12% the approvals.
The Food and Drug Administration created the breakthrough therapy designations in 2012 in order to incentivize R&D and expedite review for drugs addressing critical conditions.
Since the inception of the program, the FDA has approved 40% of BTD requests, and while the administration originally promised to review all requests within 60 days, review times now stand at an average of nine to ten months.
But the EP Vantage report suggests big pharma companies have a significant advantage both in procuring BTDs and receiving expedited approval through the process.
Specifically, the life-science market intelligence firm showed small companies with BTDs got their drugs to market in an average of 8.2 months, compared with 5.5 months for larger companies. There were, however, far fewer small companies represented in the sample analyzed.
Amgen, for example, saw its B-cell acute lymphoblastic leukemia drug Blincyto processed by the FDA in just 2.5 months. By contrast, Alexion’s lysosomal acid lipase deficiency drug Kanuma took 11 months to receive approval.
Roche's Esbriet took 59.4 months to gain approval, but EP Vantage deemed this case an outlier.
The FDA also appears to more readily approve breakthrough-designated oncology drugs.
Of the 31 drugs designated and approved by the FDA, a total of 15 were in oncology, compared to 5 in hepatitis C and 4 in fibrosis.
On average cancer drugs with BTDs took just 4.6 months to be approved, while fibrosis drugs (excluding Roche’s Esbriet) took an average of 6 months and hepatitis C drugs were processed in an average of 8 months.