Accelerated Approval

Accelerated Approval

A regulatory mechanism developed by the US FDA to make new drug products available for serious or life threatening diseases when they appear to provide a benefit over available therapy—or when there is no effective treatment.
References in periodicals archive ?
M2 EQUITYBITES-March 14, 2018-Sarepta Therapeutics to submit new drug application for accelerated approval of Golodirsen
M2 PHARMA-March 14, 2018-Sarepta Therapeutics to submit new drug application for accelerated approval of Golodirsen
Credit Suisse analyst Alethia Young raised her price target on Sarepta Therapeutics to $100 from $81, citing accelerated approval potential on golodirsen and her increasing excitement around upcoming initial gene therapy data around mid-2018.
AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Calquence (acalabrutinib).
Ocaliva was granted accelerated approval for the treatment of primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
The company, Genervon Biopharmaceuticals LLC, last fall took the unusual and aggressive step of asking the Food and Drug Administration for accelerated approval of its drug candidate, GM604, after a small but promising Phase II trial involving ALS patients.
Food and Drug Administration (FDA) has given accelerated approval to the drug olaparib (Lynparza) for treatment of advanced ovarian cancer.
A product can receive accelerated approval if a follow-up clinical study confirming the anticipated clinical benefits is conducted.
Accelerated approval: The accelerated approval process was also implemented to shorten the approval time by permitting the use of surrogate end-points in clinical trials to reasonably predict that the new medication will be effective.
No formal votes were taken, but most members of an FDA advisory panel are backing agency intentions to tighten the accelerated approval process for oncology drugs.
The FDA gave Intelence preliminary approval in January 2008 under its accelerated approval program, which allowed J&J to market the drug.
This report provides information on (1) all drug applications approved based on surrogate endpoints in FDA's accelerated approval process, (2) a subset of applications for potentially innovative drugs approved based on surrogate endpoints under FDA's traditional process, and (3) FDA's oversight of postmarketing studies.
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