AstraZeneca Plc and Amgen Inc (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration has granted a breakthrough therapy label for the two companys’ drug Tezepelumab.
Tezepelumab, an injectable treatment, is intended to treat a type of severe asthma. The breakthrough therapy label potentially speeds up the development and regulatory review.
According to data from a mid-stage trial in 2017, out of 584 patients, tezepelumab reduced the annual rate of serious asthma attacks, known as exacerbations, by between 61 percent and 71 percent, depending on dose. The drug is currently in late-stage trials.
According to David Reese, an executive vice president of Research and Development at Amgen, “The Phase 2b PATHWAY trial data demonstrated tezepelumab’s promise as a novel therapeutic option for a broad population of patients with severe asthma, including those ineligible for currently approved biologic therapies.”
“The Breakthrough Designation will give us the opportunity to work closely with the FDA to bring tezepelumab to patients as quickly as possible.”
The PATHWAY Phase 2b data were published in the New England Journal of Medicine and presented at the European Respiratory Society International Congress last September.
This was great news for AstraZeneca as not too long ago, Anifrolumab, its experimental treatment for lupus, had missed its primary endpoint in a study.
Lupus is a hard-to-treat condition that may even be life threatening in some cases.
The drug failed to meet the goal of a late-stage trial that had 373 patients. Patients in the study did not see a statistically significant reduction in disease activity compared with those who received a placebo in the yearlong study.
“The result of this trial is disappointing for patients and the lupus community,” said Sean Bohen, Astra’s executive vice president for global medicines development.
The full evaluation of the data from the trial, called Tulip 1, will be conducted later this year.
“SLE is a debilitating autoimmune disease with significant unmet need among patients who struggle to achieve meaningful disease control,” remarked Bohen.