Breakthrough Status May Not Be So Groundbreaking, Recent Reviews Indicate
A look at some of FDA’s novel drug approvals analyzed in Pharmaceutical Approvals Monthly’s 2012 series of drug review profiles suggests that the agency has already ushered through several approvals that could be models for the new “breakthrough” designation created by the FDA Safety and Innovation Act.
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Flexibility Or Formal Pathway? Avycaz Suggests FDA Doesn't Need Congress To Expedite Limited Use Antibiotics
FDA steered Actavis' antibiotic Avycaz to approval for limited use based on limited data through the 505(b)(2) pathway, helped along by the agency's regulatory flexibility for medically important agents – making the Limited Population Antibiotic Development pathway under discussion on Capitol Hill look redundant.
Roche’s key HER2 breast cancer franchise boasted a stellar sales performance in the first-quarter – rising 27% in the U.S. alone – and the rest of the cancer business followed suit. But, the loss of schizophrenia candidate bitopertin casts a shadow on the firm’s plans for neuroscience.
Companies receiving breakthrough designations seem just as unclear as investors about the value of the program.