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MannKind吸入式胰岛素药物Afrezza获得FDA批准

来源:生物谷 2014-06-28 19:48

2014年6月28日讯 /生物谷BIOON/ --FDA在本周五正式批准MannKind公司的吸入式胰岛素药物Afrezza上市,这是MannKind公司在投入数亿美元,第三次申请后才获得了他们梦寐以求的许可。糖尿病市场极为巨大,仅在美国就有2600万人患有二型糖尿病,而此前注射胰岛素一直是治疗这一疾病的主流疗法。现在Afrezza将为患者们提供更简便的一种选择。MannKind公司为Afrezza的研发倾注了巨大心力,仅FDA审核时间就超过了5年。2011年,Afrezza因为可能副作用而被FDA否决,此后MannKind公司花费数亿美元再次进行临床三期研究。而同一时期辉瑞公司不得不放弃其胰岛素吸入药物Exubera。(生物谷Bioon.com)

详细英文报道:

Three years and hundreds of millions of dollars after MannKind was handed its second FDA rejection onAfrezza, the third time proved the charm for the inhaled insulin. The FDA on Friday handed out its blessing for MannKind ($MNKD) to start marketing the drug, which will now set out to see if it can succeed with an inhaled insulin after Pfizer's ($PFE) Exubera failed so spectacularly at the task.

The market is huge. Some 26 million Americans have Type 2 diabetes, threatened by high levels of blood sugar. MannKind--cheered, chaired and financed to a large degree by Al Mann--has long believed that its inhaled insulin offered an easier way for many of those people to control the disease. But after Pfizer had failed to make a go of it, potential major league partners kept their distance, forcing the biotech to dig deep--and borrow more--to finish the last two Phase III studies.

"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "Today's approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels."

Afrezza has been under FDA review off and on for the past 5 years and was rejected for a second time in 2011 after the company switched inhalers while it was under consideration. The writing on the wall for Afrezza finally looked good for the biotech following an overwhelmingly positive FDA panel vote on April 1. The outside experts clearly felt that investigators had provided a positive look at the risk/benefit profile of the treatment. The vote in its favor came despite an internal FDA review that raised fresh questions about risks of bronchial spasms, an impact on lung function as well as the efficacy data on Type 1 patients.

The FDA noted in its release that Type 1 diabetics who use Afrezza will need to continue to use a long-acting insulin. The agency also laid out a risk mitigation plan and requirements for a slate of post-marketing studies to examine risk as well as patients' reactions to the therapy.

Skeptics have focused plenty of negative attention on MannKind over the years. But back in 2011, MannKind borrowed $370 million to rerun the inhaled drug in Phase III. The same skeptics, though, have downplayed this dry powder's ability to compete against well established injectables, especially after much bigger companies have tried and failed before.

Pfizer pulled Exubera from the market back in 2007, a little more than a year after the agency handed out its endorsement, Jinxed by a high price and hard-to-use inhaler, patients stayed away in droves and predictions of certain blockbuster status had quickly evaporated.

MannKind's response, though, is that Afrezza's formulation and inhaler is different than its predecessors. Now it will have to prove itself all over again. Analysts estimate the treatment should be able to earn about $600 million a year. MannKind's shares slipped about 6% at the close today.

 

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