Claim: FDA gives fast track status to AstraZeneca's diabetes drug Farxiga.
Verdict: SUPPORTS

Retrieved passages:
title: Diana Zuckerman
text: committees to testify as a medical expert on a variety of drugs and devices. On December 12, 2013, Zuckerman testified regarding the type-2 diabetes drug dapagliflozin (Farxiga), saying: "My concern about this drug is that there are just too many unanswered questions – and those unanswered questions are frightening ones. That was true when the FDA rejected this application for approval 2 years ago, and it is still true today." She cited studies that highlighted the risks that the drug poses, as well as methodological concerns such as a lack of diversity in clinical trials. On November 14, 2012, Zuckerman

title: Dapagliflozin
text: Dapagliflozin Dapagliflozin (INN, USAN, trade name Farxiga in the U.S. and Forxiga in the EU and Russia) is a drug of the gliflozin class, used to treat type 2 diabetes. It was developed by Bristol-Myers Squibb in partnership with AstraZeneca. In July 2011 a U.S. Food and Drug Administration (FDA) endocrinologic and metabolic drugs advisory committee recommended against approval until more data were available. The FDA approved dapagliflozin on January 8, 2014 for glycemic control, along with diet and exercise, in adults with type 2 diabetes. In 2012, the Committee for Medicinal Products for Human Use (CHMP) of the European

title: Dapagliflozin
text: than one thousandth of the IC for SGLT1 (1.1 versus 1390 nmol/L), so that the drug does not interfere with intestinal glucose absorption. Clinical trials to assess effectiveness for patients with type 1 diabetes are underway. Dapagliflozin Dapagliflozin (INN, USAN, trade name Farxiga in the U.S. and Forxiga in the EU and Russia) is a drug of the gliflozin class, used to treat type 2 diabetes. It was developed by Bristol-Myers Squibb in partnership with AstraZeneca. In July 2011 a U.S. Food and Drug Administration (FDA) endocrinologic and metabolic drugs advisory committee recommended against approval until more data were available.

title: Steven Nissen
text: the Bristol-Myers Squibb drug Pargluva (muraglitazar), an experimental type 2 diabetes drug. When an U.S. Food and Drug Administration (FDA) advisory panel charged with reviewing the clinical trial data approved the drug, he immediately began an in-depth analysis. In 2007, the meta-analysis by Nissen and his co-investigator Kathy Wolksi, published in the Journal of the American Medical Association online on October 20, found that the diabetes drug rosiglitazone (Avandia) produced by GlaxoSmithKline carried high cardiovascular risks. The FDA issued an alert on May 21, 2007, leading to a warning by the Food and Drug Administration and a sales loss of

title: Saxagliptin
text: rights to develop and commercialize the compound in Japan. Under the licensing agreement, Otsuka will be responsible for all development costs, but Bristol-Myers Squibb retains rights to co-promote saxagliptin with Otsuka in Japan. Further, on 11 January 2007 it was announced that Bristol-Myers Squibb and AstraZeneca would work together to complete development of the drug and in subsequent marketing. Saxagliptin Saxagliptin, sold under the brand name Onglyza, is an oral hypoglycemic (anti-diabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Early development was solely by Bristol-Myers Squibb; in 2007 AstraZeneca joined with Bristol-Myers Squibb to co-develop the final compound and

title: AstraZeneca
text: been commercialised. The drug was developed jointly by FibroGen and AstraZeneca. Unlike Erythropoietin (EPO), which directly stimulates the production of red blood cells, FG-4592 is taken orally, and stimulates natural production of EPO in a manner similar to altitude training. AstraZeneca AstraZeneca plc is an Anglo–Swedish multinational pharmaceutical and biopharmaceutical company. In 2013, it moved its headquarters to Cambridge, UK, and concentrated its R&D in three sites: Cambridge; Gaithersburg, Maryland, USA (location of MedImmune) for work on biopharmaceuticals; and Mölndal (near Gothenburg) in Sweden, for research on traditional chemical drugs. AstraZeneca has a portfolio of products for major disease areas

title: Fast track (FDA)
text: resolved quickly, often leading to earlier drug approval and access by patients. Fast track (FDA) Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. Fast Track is one of five Food and Drug

title: Lanabecestat
text: that they received FDA fast track designation for lanabecestat. On June 12, 2018, Lilly and AstraZeneca announced that the two ongoing Phase III clinical trials for lanabecestat were not likely to meet their primary endpoint and that all current trials would be stopped due to futility. Lanabecestat Lanabecestat (formerly known as AZD3293 or LY3314814) is an oral beta-secretase 1 cleaving enzyme (BACE) inhibitor. A BACE inhibitor in theory would prevent the buildup of beta-amyloid and may help slow or stop the progression of Alzheimer's disease. In September 2014, AstraZeneca and Eli Lilly and Company announced an agreement to co-develop lanabecestat.

title: Empagliflozin
text: the kidney and thereby excreting glucose (i.e., blood sugar) via the urine. As of May 2013, Boehringer and Lilly had submitted applications for marketing approval to the European Medicines Agency and the U.S. Food and Drug Administration (FDA). The drug was approved in Europe in May 2014 and was approved by the FDA in August 2014. The FDA required four postmarketing studies: a cardiovascular outcomes trial, two studies in children, and a toxicity study in animals related to the pediatric trials. Empagliflozin Empagliflozin (trade name Jardiance among others) is a medication of the gliflozin class, approved for the treatment of

title: AstraZeneca
text: COPD drug, Eklira. The $2.1 billion deal included an allocation of $1.2 billion for development in the respiratory franchise, one of AstraZeneca's three target therapeutic areas announced the year before. In August 2014 the company announced it had entered into a three-year collaboration with Mitsubishi Tanabe Pharma on diabetic nephropathy. In September 2014 the company would join forces with Eli Lilly in developing and commercialising its candidate BACE inhibitor – AZD3292 – used for the treament of Alzheimers. The deal could yield up to $500 million for the company. In November 2014 the company's biologics R&D operation, MedImmune, agreed to

title: Ceftazidime/avibactam
text: (QIDP) designation for new drug candidates. Drugs given the QIDP designation must be indicated to treat serious and/or life-threatening diseases.The QIDP designation extends the patent life for 5 additional years for qualifying drugs and makes the drug eligible for fast tracking by the FDA. This effort was initiated to introduce new drugs on the market to treat serious infections for which effective therapy is currently absent or in short supply. Avycaz is the fifth drug to receive this designation since the enacting of the program. Avycaz will be marketed in North America through Allergan Inc., while AstraZeneca will market it

title: Orphan drug
text: to increase their profit margin. For example AstraZeneca's cholesterol drug Crestor was filed as a treatment for the rare disease pediatric familial hypercholesterolemia. After the drug was approved for orphan drug designation, and AstraZeneca had received tax breaks and other advantages, AstraZeneca later applied and received FDA approval for the drug to be used to treat cholesterol in all diabetics. By 2008 if an orphan drug cost more than £30,000 the NICE required other arguments for funding. In 2015, NICE held consultations with "patient groups, the Department of Health, companies, learned societies, charities and researchers" regarding the appraisal of medicines

title: Fast track (FDA)
text: Fast track (FDA) Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. Fast Track is one of five Food and Drug Administration (FDA) approaches to make new drugs available as rapidly as possible:

title: Lisinopril
text: and the drug was approved for hypertension in 1987 and congestive heart failure in 1993. The discovery posed a problem, since sales of enalapril were strong for Merck, and the company did not want to diminish those sales. Merck ended up entering into an agreement with Zeneca under which Zeneca received the right to co-market lisinopril, and Merck received the exclusive rights to an earlier stage aldose reductase inhibitor drug candidate, a potential treatment for diabetes. Zeneca's marketing and brand name, "Zestril", turned out to be stronger than Merck's effort. The drug became a blockbuster for Astrazeneca (formed in 1998),

title: Liraglutide
text: product was approved for treatment of type 2 diabetes by the European Medicines Agency (EMA) on July 3, 2009, and by the U.S. Food and Drug Administration (FDA) on January 25, 2010. More recently, Liraglutide was approved by the FDA on December 23, 2014 and by the European Medicines Agency on January 23, 2015, for adults with a body mass index (BMI) of 30 or greater (obesity) or a BMI of 27 or greater (overweight) who have at least one weight-related condition. Liraglutide is a once-daily injectable derivative of the human incretin glucagon-like peptide-1 (GLP-1), for the treatment of type

title: Saxagliptin
text: diabetes was submitted to the FDA in June 2008. It was based on a drug development program with 8 randomized trials: 1 phase 2 dose-ranging (2.5–100 mg/d) study; 6 phase 3, 24-week controlled trials with additional controlled follow-up from 12 to 42 months, double-blinded throughout; and one 12-week mechanism-of-action trial with a 2-year follow-up period. The FDA approved saxagliptin with brand name Onglyza on July 31, 2009. Saxagliptin was licensed for use throughout the European Union by the European Medicines Agency on December 1, 2009. Bristol-Myers Squibb announced on 27 December 2006 that Otsuka Pharmaceutical Co. has been granted exclusive

title: Food and Drug Administration
text: ibuprofen. In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program, but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This is seen as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and continued . The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics,

title: Fast track (FDA)
text: Fast Track designation is eligible for some or all of the following: An FDA decision not to grant Fast Track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency’s procedures for internal review or dispute resolution if necessary. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are

title: Saxagliptin
text: Saxagliptin Saxagliptin, sold under the brand name Onglyza, is an oral hypoglycemic (anti-diabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Early development was solely by Bristol-Myers Squibb; in 2007 AstraZeneca joined with Bristol-Myers Squibb to co-develop the final compound and collaborate on the marketing of the drug. In April 2016, the U.S. FDA added a warning about increased risk of heart failure. This was based on data in an article that concluded "DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events, though the rate of hospitalization for heart failure was increased. Although saxagliptin improves

title: AstraZeneca
text: acquire Definiens for more than $150 million. The company also began a Phase I/II trial collaboration with Pharmacyclics and Janssen Biotech investigating combination treatments. Also in November of the same year, the company agreed to sell its lipodystrophy treatment business to Aegerion Pharmaceuticals for more than $325 million. In December, the company received accelerated FDA approval for Olaparib in the treatment of women with advanced ovarian cancer who have a BRCA genetic mutation. A major criterion governing the drugs approval was, on average, its ability to shrink tumours in patients for 7.9 months. In February, the company announced it would