AstraZeneca gets approvals for Fasenra and Lynparza in Japan

The FTSE 100 drugmaker issued the announcement for Fasenra with its global biologics research and development arm MedImmune, saying the approval by the Japanese Ministry of Health, Labour and Welfare was based on the results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III oral corticosteroid-sparing trial, ZONDA.

Fasenra would be available as a fixed-dose subcutaneous injection in a prefilled syringe administered once every four weeks for the first three doses, and then once every eight weeks thereafter.

“The approval of Fasenra, our first respiratory biologic medicine, in Japan closely follows the recent US and EU decisions and brings us another step closer to achieving our ambition of transforming care for severe asthma patients around the world,” said the company’s chief medical officer and executive vice president of global medicines development, Sean Bohen.

AstraZeneca said Fasenra binds directly to the IL-5α receptor on eosinophils, a type of white blood cell that are a normal part of the body's immune system, and attracts natural killer cells to induce direct, rapid and near-complete depletion of eosinophils via apoptosis, or programmed cell death.

Elevated levels of eosinophils, seen in about half of severe asthma patients, impacted airway inflammation and airway hyper-responsiveness, resulting in increased asthma severity and symptoms, decreased lung function and increased risk of exacerbations, it explained in its announcement.

The Japanese approval follows US FDA approval in November and European Commission marketing authorisation earlier in January.

Interactions with regulatory authorities in the rest of the world were said to be ongoing.

The announcement about Lynparza, which was release alongside Merck & Co, confirmed the drug is the first poly ADP-ribose polymerase (PARP) inhibitor to be approved in Japan.

“We are proud to bring this important first-in-class treatment to women with platinum-sensitive relapsed ovarian cancer in Japan who currently have very few treatment options,” said AstraZeneca’s head of the oncology business unit, Dave Fredrickson.

“The trials show that with Lynparza maintenance therapy, women with ovarian cancer can live longer without their disease worsening and Lynparza is well tolerated.”

Roy Baynes, senior vice president and head of global clinical development, and chief medical officer at Merck’s MSD Research Laboratories, said: the decision was “significant” for Lynparza and, more importantly, for Japanese patients living with advanced ovarian cancer.

“Our global collaboration with AstraZeneca reinforces how our joint efforts can advance science for patients, and we look forward to working together to explore the potential of Lynparza across multiple tumour types,” Baynes added.

The approval was granted on the basis of two randomised trials of Lynparza maintenance therapy for platinum-sensitive relapsed ovarian cancer, SOLO-2 and Study 19.

In SOLO-2, the most common adverse drug reactions of any grade reported in patients in the Lynparza arm were nausea at 66.7%, anaemia at 39.0%, fatigue at 29.7%, vomiting at 25.6%, asthenia at 24.1% and dysgeusia at 23.1%.

The most common adverse drug reactions of any grade reported in patients in the Lynparza arm in Study 19 were nausea at 64.0%, fatigue at 43.4% and vomiting at 21.3%.

Lynparza was also currently under review for use in unresectable or recurrent BRCA-mutated, HER2-negative breast cancer in Japan, AstraZeneca explained, with a decision expected in the second half of 2018 based upon a priority review.