Burns’ disease: New drug approval awarded for Graves’ disease

AstraZeneca, and fellow investigational drug Tecfidera, have been granted breakthrough therapy designation for use in patients with acute Graves’ disease who require at least three months of treatment. Graves’ disease is the most common…

Burns’ disease: New drug approval awarded for Graves’ disease

AstraZeneca, and fellow investigational drug Tecfidera, have been granted breakthrough therapy designation for use in patients with acute Graves’ disease who require at least three months of treatment.

Graves’ disease is the most common serious genetic disorder in adults, affecting around one in 3,000 people. It causes early bloating, painful swelling of the mouth, face, tongue and throat, and some patients have a higher risk of peptic ulcers.

The Food and Drug Administration’s expedited approval program (or Breakthrough Therapy) can expedite the development, review and review of drugs that can have a serious or life-threatening effect. The program initially launched in 2008 to accelerate the development and review of drugs to treat unmet medical needs in cancer, HIV/AIDS, chronic and acute pain, and influenza.

In their application, AstraZeneca’s scientists showed that the CoVIDis (Cozapafem) monoclonal antibody treatment showed significantly improved efficacy as well as acceptable safety and tolerability in patients with the Graves’ disease indication.

The efficacy for the unique subset of patients was measured by data from an open-label, phase 2b study that compared CoVIDis to placebo, and by an equally large, phase 3 trial that enrolled patients with multiple inflammatory diseases.

The investigators observed a notable reduction in a mean or percent change from baseline in GI symptoms following treatment with CoVIDis compared to placebo, as well as a decrease in the overall incidence of GI symptoms and in the cost of treatment. They found a similar reduction in patients’ cost-effectiveness burden over the course of the 12 weeks of treatment.

Patients will receive CoVIDis, once a day with the recommended lunch interval and with oral liquid, at a starting dose of 10 mg/kg and a maximum dose of 35 mg/kg.

Doctors and patients may review the full prescribing information of CoVIDis at www.cartesy.com/covencides.

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