Japan's latest approvals include Praluent in second PCSK9 inhibitor


Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing and manufacturing authorization for Praluent (alirocumab) to Regeneron Pharmaceuticals ($REGN) and Sanofi ($SNY), marking the second PCSK9 inhibitor nod in the country following Repatha (evolocumab) from Astellas Pharma earlier this year.

The approval covers use of the therapy with statins for hypercholesterolemia patients with a high risk of cardiovascular events.

The ministry also awarded the world's first approval worldwide for brodalumab to treat psoriasis with Kyowa Hakko Kirin holding rights in Japan under the name Lumice for the drug developed by a Kirin-Amgen ($AMGN) joint venture. Kirin, which also has rights in some Asian markets, made the filing after successful Phase III trials in Japan.


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Amgen exited a pact with AstraZeneca ($AZN) for the candidate in 2015 after a Phase III trial showed possible links to suicidal behavior. AstraZeneca shed its rights outside of Asia to Valeant Pharmaceuticals ($VRX) in 2015 as well.

In addition, another antibody therapy, Kyprolis (carfilzomib), for patients with multiple myeloma won the ministry's nod with the candidate from Ono Pharmaceutical licensed from Onyx Pharmaceuticals, now a unit of Amgen.

The ministry approved two epilepsy drugs. The first, Vimpat (lacosamide), is from UCB Group/Daiichi Sankyo and is used in addition to existing treatments for partial-onset seizures. The second is Okunobel from Nobelpharma, slated to be used with Duodopa (levodopa/carbidopa) from Novartis ($NVS) and AbbVie ($ABBV) in Parkinson's disease.

Separately, Juniper Pharmaceuticals ($JNP) said it received an MHLW nod for Crinone (progesterone gel) through Merck KGaA's biopharma business in Japan. Merck KGaA holds worldwide marketing rights to Crinone outside of the U.S. where it is marketed by Allergan ($AGN).

Following drug approvals, Japan's Central Social Insurance Medical Council known as Chuikyo determines reimbursement criteria, including prices, in a process that can take months before actual launch.

- here's the MHLW website
- along with the Praluent release
- and the Onecrinone release

Related Articles:
Japan's MHLW names Tomonori Nakayama to key reimbursement post
Two's company for PCSK9 meds as Praluent, Repatha both nab coverage from top PBM

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