EP Vantage: A Breakthrough Year for Unmet Diseases

EP Vantage: A Breakthrough Year for Unmet Diseases


EP Vantage's report A Breakthrough Year for Unmet Diseases reveals that since the FDA's breakthrough therapy designation (BTD) was put into effect in July of 2012, pharma and biotech companies have certainly taken note.

The list of 30 disclosed BTD projects so far reveals that the vast majority have favoured big pharma and big biotech despite the FDA's promise to provide assistance on clinical trial design and guidance on development, which were aimed at the small, cash-strapped biotechs.

Key findings include:

  • No fewer than 141 BTDs have been applied for, of which, 37 have been granted.
  • Three breakthrough-designated products have received US approval: Roche's Gazyva; J&J/Pharmacyclics' Imbruvica; Gilead's Sovaldi
  • Large companies in phase III projects dominate the disclosed breakthrough therapy projects to date
  • The various accelerated pathways have become a part of the product development landscape

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