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eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that on july 26, 2017 (u.s. time), its u.s. subsidiary eisai inc. received approval from the u.s. food and drug administration (fda) for a supplemental new drug application (snda) for eisai’s antiepileptic drug (aed) fycompa (perampanel) as monotherapy use for the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that it has submitted applications to the us food and drug administration (fda) and the european medicines agency (ema) for its in-house discovered and developed anticancer agent lenvatinib mesylate (lenvatinib) for the treatment of hepatocellular carcinoma (hcc). this follows the application in japan. lenvatinib for the treatment of hcc is designated as an orphan drug by the fda.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the results of a phase iii trial (study 304) of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) against the comparator sorafenib as first-line treatment for unresectable hepatocellular carcinoma, will be orally presented during the 53rd annual meeting of the american society of clinical oncology (asco), taking place in chicago, the united states. in this study, lenvatinib was the first agent to demonstrate statistical non-inferiority against sorafenib in the primary endpoint of overall survival (os) and showed statistically significant and clinically meaningful improvements in the secondary endpoints of progression free survival (pfs), time to progression (ttp), and objective response rate (orr), doubling sorafenib‘s median values and ratios.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced the first results for metastatic endometrial carcinoma obtained from a phase ib/ii study (study 111) of its in-house developed multi-kinase inhibitor lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) in combination with the msd (known as merck & co., inc, kenilworth, nj, usa in the united states and canada) anti-pd-1 antibody pembrolizumab (brand name: keytruda®*), during a presentation at the 53rd annual meeting of the american society of clinical oncology (asco), taking place in chicago, the united states. the two companies are collaborating to develop this combination therapy. study 111 is being conducted to evaluate the activity of the lenvatinib/pembrolizumab combination in select solid tumors.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that it will grant a total of 500 million yen to the global health innovative technology fund (“ghit fund”) to fund the second phase of its activities, which will take place in the five-year period from fy 2018 to fy 2022. the ghit fund is a public-private partnership, co-established in april 2013 by multiple japanese pharmaceutical companies (including eisai), the japanese government, and the bill & melinda gates foundation, for the purpose of accelerating development of new medicines to cure infectious diseases in developing and emerging countries by facilitating collaboration between research organizations in japan and overseas.

on april 19, 2017, eisai china inc. (hereinafter referred to as: eisai (china)) was invited to attend the “health to countryside” activity held in yudu county, jiangxi province by the national committee for education, science, culture, health and sports of chinese people’s political consultative conference (cppcc), and donated medicines worth rmb540,000 yuan to the local hospitals. according to the statistics, eisai (china), practicing the philosophy of hhc (human health care) all along, donated medicines worth rmb450,000, rmb490,000, rmb500,000 and rmb540,000 respectively to this activity from the year 2014 to 2017, with the total worth of medicines reaching up to rmb1.98 million yuan.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that, approaching the 65th anniversary of its chocola bb brand, it will launch chocola bb® gold rich (designated quasi-drug), a supplement drink recommended to relieve fatigue, on monday, april 17.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and meiji seika pharma co., ltd. (headquarters: tokyo; ceo: daikichiro kobayashi, “meiji”) announced today that they have entered into a license agreement for the commercialization of safinamide (development code: me2125) for the treatment of parkinson’s disease in japan and asia. safinamide is currently under clinical development by meiji in japan.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has presented the latest research data regarding a mechanism of action that led to increased anti-tumor activity in mouse models which had been dosed with a combination of the in-house developed anticancer agent lenvatinib mesylate (lenvatinib) and an anti-mouse pd-1 antibody, at the american association for cancer research (aacr) 108th annual meeting.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai” ) announced today that the german federal joint committee (g-ba) has confirmed the additional benefit of in-house developed anticancer agent kisplyx® (lenvatinib mesylate) in combination with everolimus for the treatment of advanced renal cell carcinoma (rcc) compared to everolimus alone in its assessment for insurance reimbursement. based on this additional benefit assessment, price negotiations with the head association of german sick funds (gkv-sv) will be conducted, and a reimbursement price has to be agreed. 

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