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Eli Lilly diabetes mellitus antidiabetic drug empagliflozin by FDA refused
2014-08-02
来源：转载自第三方
Boehringer Ingelheim - Eli Lilly diabetes mellitus antidiabetic drug empagliflozin by FDA refused. The alliance said in March 5th, the FDA has empagliflozin new drug application (NDA) issued a complete response letter (CRL). In the letter, FDA mentioned defects had found in Blyngju G John empagliflozin production factories. FDA points out, these problems need to be solved in the empagliflozinNDA approved before. But the FDA is not required to carry out any new clinical trials to support empagliflozinNDA approval. The alliance said, will soon submit to complete response letter response, also will work closely with FDA, the empagliflozin approved the listing as soon as possible, for the benefit of patients with type 2 diabetes mellitus.
FDA mentioned the problem of Blinger on the Rhine River plant. Last spring, FDA issued a warning letter, not scold's due diligence of large particle contamination of several batches of active pharmaceutical ingredients in the factory. At that time, Blinger said, will take seriously the FDA warning, but at the same time, the factory has passed the check 22 times in the past 5 years.
The empagliflozin refused to Eli Lilly, brought no small trouble, the company has pledged this year to harvest "several" new drug approval, to make up for the shortcomings of long new drug approval. If empagliflozin is FDA indefinitely, the Lilly can in this year may only GLP-1 diabetes drug dulaglutide and anticancer drug ramucirumab, these 2 drugs have been accumulated positive phase III huge data.
At the same time, the group is also following a few weeks ago Lilly developed Lantus (Lantus) latest hit generics shelved. Previously, Sanofi sued Lilly, Lilly said infringed on 4 of its patents. But the legal wrangle, is likely to delay the Lilly Lantus generics market, until the middle of 2016.
In addition, the best candidates for empagliflozin still represents the Lilly with other pharmaceutical company SGLT-2 inhibitors compete, such as Johnson Invokana, AstraZeneca and Bristol Myers Farxiga (dapagliflozin). Invokana in 2013 November approved by FDA, Farxiga after a long delay after the final examination in January this year, approved by FDA.
Empagliflozin belongs to the sodium glucose co transporter -2 (SGLT-2) inhibitor drugs, treatment is investigated for adult patients with type 2 diabetes. The new SGLT-2 inhibitors, has been confirmed by resorption to block renal glucose, glucose excretion excessive to in vitro, which can reduce the blood glucose level, but the hypoglycemic effect does not depend on the function and beta cell insulin resistance.
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