A Food and Drug Administration advisory panel has backed the approval of the hereditary angioedema drug icatibant, to be marketed as Firazyr.
Firazyr’s manufacturer, Shire, will enter discussions with the FDA on labeling for the drug, with backing from the panel for a claim to allow patients to self-administer the product, which is delivered through subcutaneous injection.
The Pulmonary-Allergy Drugs Advisory Committee voted 11-1, with one abstention, on June 23 that data for the bradykinin B2 receptor antagonist support self-injection of the drug, which is proposed to treat acute attacks of HAE in adults at a dose of 30 mg.
The panel supported approval of Firazyr by a vote of 12-1, following votes of 12-1 that data provide substantial and convincing evidence that it has a clinically meaningful benefit in acute HAE attacks, and 11-1, with one abstention, that its safety has been adequately addressed.
The "real benefit of this medication that I see will be self-medication," said Dr. Thomas Alexander Platts-Mills of the University of Virginia, Charlottesville.
It will put patients in control, enabling them to get therapy more quickly and to reduce the anxiety of seeking treatment from an emergency department that may or may not be equipped to treat the disease, he noted.
Fully half of hospitals do not have on hand a treatment for HAE acute attacks, and most will not administer a drug brought in by a patient, said Dr. Jay Portnoy of Children’s Mercy Hospitals and Clinics in Kansas City, Mo., so patients with HAE should be equipped to treat themselves, much as epinephrine can be self-administered. Firazyr will probably be used off label for self-administration anyway, he added.
The company is "very gratified" by the committee’s comments in support of self-administration, Suzanne Bruhn, Ph.D., senior vice president for strategic planning and program management for Shire Human Genetic Therapies, told reporters following the meeting.
The self-administration claim would distinguish Firazyr from competitors that are already in the U.S. market for acute HAE attacks. For example, Dyax Corp.’s Kalbitor (ecallantide) is delivered subcutaneously, but because of the potential for anaphylaxis, it must be administered by a health care professional. CSL Behring’s Berinert, which is used only for attacks affecting the face and abdominal area, is delivered intravenously.
Firazyr already is approved for self-administration in Europe and Australia.
Shire HGT would launch the drug within a few weeks of approval, using the experience and infrastructure built up to market its other orphan products, Dr. Bruhn said. Firazyr has an Aug. 25 Prescription Drug User Fee Act date.
This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are owned by Elsevier.