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FDA第三次否决艾尔建公司偏头痛药物Semprana

来源:生物谷 2014-07-11 08:59

2014年7月11日讯 /生物谷BIOON/ --近日FDA作出决定,再次否决艾尔建公司开发的新型吸入式偏头痛药物Semprana的上市申请。这无疑使艾尔建公司雪上加霜。由于Valeant公司正在尝试收购艾尔建公司,所以他们继续一次成功来证明自己的研发实力。另一方面,这也是FDA第三次否决这一药物,FDA此次认为艾尔建公司需要提供Semprana更详细的生产数据、化学性质等方面的信息才能最终作出决定。FDA此次这一决定使Semprana的可能获批日期至少推迟到2015年第二季度。

近几周来,Valeant公司不断与艾尔建公司交换信息,直到前不久,Valeant公司正式开出了高达530亿美元的高价。这一报价甚至已经获得了艾尔建部分股东的认同。(生物谷Bioon.com)

详细英文报道:

The FDA has handed out its third rejection of a new, inhalable migraine therapy Allergan ($AGN) had hoped could be used to help fend off Valeant's ($VRX) buyout bid. The big biotech did get some good news, though, announcing that the agency approved Ozurdex for diabetic macular degeneration.

In an R&D update out this morning Allergan--best known for its wrinkle-removerBotox--put out the word that regulators had once again turned their thumbs down on Semprana, formerly known as Levadex. The drug had already been rejected by the FDA before Allergan acquired the migraine therapy in the billion-dollar buyout of MAP Pharmaceuticals in early 2013. Now Allergan says that any approval will likely be delayed until the second quarter of 2015.

The FDA issued its first CRL on the therapy in the spring of 2012, with a detailed list of demands for more information on MAP's chemistry, manufacturing and controls process as well as more time to inspect a third-party manufacturer's facility and review the company's inhaler. But last spring the FDA had lingering manufacturing concerns, triggering another rejection for the inhalable version of a 60-year-old treatment. And today the company is still struggling to get this program through the approval process--citing the FDA's questions on "specifications around content uniformity on the improved canister filling process and on standards for device actuation."

An approval here would have helped Allergan argue against Valeant's $53 billion buyout with fresh evidence of its ability to develop new therapies--something Valeant has never been keen about. Instead it had to trumpet the news about Ozurdex and downplay Semprana.

The approval of Ozurdex for certain patients with DME further strengthens Allergan's leadership position in ophthalmology and the retina subspecialty," said Scott M. Whitcup, the CSO at Allergan. "In addition to receiving this important FDA approval, we are also pleased that two of our innovative pipeline programs are advancing to Phase III clinical development. These therapies involve novel molecules or innovative drug delivery systems which may help to improve patient outcomes."

Valeant and Allergan have been exchanging harsh words just about every day for the past several weeks. Late last week Allergan and Valeant's ally, Pershing Square Capital Management, struck an agreement to call a special meeting of Allergan's stockholders without triggering a poison pill defense.

 

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