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BioCryst Berotralstat PDUFA, And Other News: The Good, Bad And Ugly Of Biopharma


  • BioCryst's Berotralstat PDUFA has been set for December 3, 2020.
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BioCryst Pharmaceuticals Goes Ahead with Expanded Access Program for Berotralstat

BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) announced launching its Expanded Access Program for berotralstat. The program will allow physicians to request the drug for hereditary angioedema patients who do not have access to the product through a clinical trial. BioCryst has filed an application with the FDA for berotralstat. The PDUFA date has been set at December 3, 2020.

As per the FDA, expanded access program is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Berotralstat is indicated for patients suffering from hereditary angioedema, which is an inherited disorder. The ailment causes recurring episodes of severe swelling. Such swelling can be found in the limbs, intestinal tract, airway and face. The drug candidate is designed to be taken orally once a day.

The company recently released long-term data for berotralstat, highlighting its safety and tolerability. The data collected from the APeX-2 trial demonstrated that 150 mg dosage of the drug reduced patients' monthly use of Standard of Care medication by 53.6 percent. It also reduced the number of HAE incidents needing acute SoC treatment by 49.2 percent in comparison to placebo. The data also showed that the percentage of HAE incidents needing re-treatment with multiple doses of on-demand therapy was lower for patients administered berotralstat than the patients who were on placebo.

Patients who were administered the drug candidate during the trial also demonstrated quick and steady decline in the frequency of their HAE incidents during the course of 48 weeks. Thirty patients who completed 48 weeks of the regimen had mean attack rate of 1.4 attacks per month after a

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