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Drugmakers take to Japan: 3 new drug approvals won by AstraZeneca, Merck, and EA Pharma

Friday morning came with three new drug approvals in Japan, including one from a multibillion dollar collaboration between pharma giants AstraZeneca $AZN and Merck $MRK.

The duo won a regulatory nod for Lynparza — now the first PARP inhibitor to be approved in Japan — and for asthma drug Fasenra.

Lynparza was the first PARP inhibitor to hit the market here in the US, and AstraZeneca followed up on the accelerated OK with more studies demonstrating its effectiveness in ovarian cancer. In August, the drug won FDA approval to be used for recurrent ovarian cancer, regardless of BRCA mutation status.

This new approval in Japan is OK-ed for the same use. The country’s medicines regulator gave the nod based on the pivotal SOLO-2 and Study 19 trials, which showed the drug achieved a 70% and 65% improvement on progression-free survival respectively over placebo.

Lynparza has proven to be a key part of AstraZeneca’s case that it can make a comeback with its oncology portfolio — a case that took a nasty hit with the recent first-round flop for its combo of Imfinzi and the CTLA-4 drug tremelimumab. Merck paid handsomely to partner on this drug in an $8.5 billion oncology collaboration with AstraZeneca announced last July.

The other win came from AstraZeneca’s biologics arm MedImmune, which won approval for Fasenra as an add-on treatment for bronchial asthma. The drug was approved in the US last November and in Europe last week.

Constipation drug approval earns Albireo $55M

Ron Cooper

The last approval in Japan this morning came from EA Pharma, a new gastrointestinal disease company formed by Eisai Group and Ajinomoto Group back in 2016. EA Pharma scored a regulatory OK to sell elobixibat for the treatment of chronic constipation in Japan.

Elobixibat is a first-in-class, once-daily, orally available IBAT inhibitor targeted to improve secretion and motility in the large bowel.

The approval triggered payments totaling $55 million to Elobix AB (a company formed by AstraZeneca spinout Albireo).

“The approval of elobixibat in Japan marks the first approval of an IBAT inhibitor anywhere in the world and provides additional validation of the innovative science on which Albireo was founded and of the promise for patients offered by bile acid modulation,” said Ron Cooper, Albireo’s president and CEO, in a statement.

Cooper added that Albireo’s lead product candidate, A4250, is also an IBAT inhibitor, and the company expects to start a Phase III for the treatment of progressive familial intrahepatic cholestasis (PFIC) by the spring of this year.


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