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【drug-news】FDA批准胰腺酶替代产品在美国上市

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super19830102

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FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States
Creon designed to help those with cystic fibrosis, others with exocrine pancreatic insufficiency
The U.S. Food and Drug Administration announced today that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods. Creon is the first FDA-approved delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the agency’s unapproved drugs initiative.

Creon, which contains a mixture of digestive enzymes extracted from the pancreas of pigs, helps patients lacking the enzymes needed to digest fats, proteins and sugars from food. Creon is approved for use in pediatric and adult patients.

The FDA had required the manufacturer of Creon to submit, and the agency has approved, a Risk Evaluation and Mitigation Strategy (REMS), which includes a Medication Guide, to advise patients on risks associated with high doses of Creon, and the theroretical risk of transmission of viral disease from pigs to patients. A rare bowel disorder, called fibrosing colonopathy, can result from a patient’s high-dose use of Creon. While this condition is serious and may require surgery, a patients’ chances of having this condition may be reduced through their adherence to dosing instructions in the labeling.

The risks of a rare bowel disorder and viral transmission described in the Medication Guide are considered to be risks related to all porcine (pig)-derived pancreatic enzyme products, including Creon.

Instructions for dosing based on weight and age should be followed carefully. Creon may be sprinkled on food. Because Creon is a delayed-release drug, patients should never crush or chew the capsule as this would cause an early release of the enzymes and a reduction in enzyme activity.

“The approval of Creon will allow patients to have access to an approved pancreatic enzyme replacement product that meets FDA standards for effectiveness, safety, and manufacturing consistency,” said Donna Griebel, M.D., director, Division of Gastroenterology Products within FDA’s Center for Drug Evaluation and Research (CDER).

The FDA’s Office of Compliance and Office of New Drugs within CDER worked with Creon’s manufacturer, Solvay Pharmaceuticals, through the agency’s unapproved drugs initiative to help the company come into compliance with federal laws by obtaining FDA approval. The agency continues to encourage the manufacturers of all other unapproved pancreatic enzyme products (PEPs) to work with the agency to obtain market approval. All PEPs must obtain FDA approval by April 28, 2010, or be removed from the marketplace.

“Like other medically necessary drugs, the FDA is exercising its enforcement discretion while it works with the manufacturer toward gaining approval of these drugs,” said Deborah Autor, director, Office of Compliance, CDER. “FDA approval is critical, and the manufacturers of these products have a responsibility to the American public to ensure that patients have drugs that meet our standards of safety, effectiveness, quality, and labeling.”

People who are allergic to pork and pork products, suffer from gout or kidney disease, have difficulty swallowing, are pregnant or who plan to become pregnant, or are breastfeeding, should discuss the use of Creon with their health care professional. Common side effects of Creon include flatulence (gassiness), abdominal pain, headache, and dizziness.

CREON and other pancreatic enzyme products are made from pancreatic organs of pigs used for food. There is a theoretical risk of contracting a viral infection from pig-derived medicines, but no human illness has been reported.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

http://www.fda.gov/bbs/topics/NEWS/2009/NEW02010.html

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2009-05-07 23:23 浏览 : 908 回复 : 3

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美国FDA批准胰酶缺乏症治疗药Creon上市

比利时Solvay公司的胰酶缺乏症治疗药Creon已正式通过FDA的批准，成为FDA颁布这类药物最新规定后首个获准的产品，这一利好消息使Solvay的股票价格大幅攀升。

Creon获准用于那些伴有囊肿性纤维化或其他疾病并导致体内胰酶不足的患者。胰酶在人体消化摄入食物中营养物质的过程中发挥着至关重要的作用，若对胰酶缺乏症不加以治疗，则有可能导致营养不良甚至死亡。

在FDA就胰酶药颁布现行规定之前，这些药物可以在未通过新药批准的情况下就可上市销售。直至2004年，FDA才规定所有胰酶药生产商必须提交新药申请才可以继续销售，到2010年，所有的胰酶药都必须按照该新规定生产和销售。

此次Creon获准的依据是一项随机、双盲、安慰剂对照临床实验中获得的数据，参加这次试验的受试者为32名囊肿性纤维化患者。与安慰剂对照组相比较，Creon受试组用药后，按照脂肪吸收系数（CFA）计算，他们体内吸收的食物脂肪成分更多。其中，Creon受试组平均CFA达到89%，而安慰剂对照组仅达到49%，这证实了药物的显著疗效。

2009-05-08 00:00

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Creon(得每通)
【分类】助消化药
【成分】每粒胶囊胰酶150mg(相当于脂肪酶10，000欧洲药典单位，淀粉酶8，000欧洲药典单位，蛋白酶600欧洲药典单位)
【适应症】胰腺外分泌不足如：慢性胰腺炎、胰腺切除术或胃切除术后、肿瘤引起的胰管或胆管阻塞。亦可用于胰腺疼痛及老年性胰外分泌不足，以及由于胰酶缺乏所引起的消化不良。
【用量用法】起始剂量为1-2粒/次，然后根据症状调整剂量。有效剂量一般为5-15粒/日。
【禁忌】急性胰腺炎早期。
【不良反应】偶见腹泻、便秘、胃不适感、恶心及皮疹。
【规格】胶囊20粒。

2009-05-08 00:01

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Solvay公司
苏威是一家国际知名的化学品和制药集团，总部设在比利时首都布鲁塞尔。她在全球50个国家拥有大约29000名员工。2008年, 苏威集团下属的三个产业部门---化工、塑料和制药的全年销售额是95亿欧元。近年来，苏威已迅速调整成为一个注重竞争力、领导地位和高附加值业务的集团，以可持续发展为目标，以对创新的热情为动力。
http://www.solvay.com/
http://www.solvay.cn/

2009-05-08 00:04

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