LYNPARZA 50 MG CAPSULE (OLAPARIB) 112'S(OLAPARIB) 已上市
奥拉帕尼胶囊，Lynparza, 50 mg hard capsules (olaparib)10月24日，EMA推荐批准阿斯利康卵巢癌药物奥拉帕尼，对奥拉帕尼（Olaparib;商品名Lynparza）来说，欧洲药品管理局的推荐是自6月份这款药物受到挫折以来受欢迎的消息，当时美国FDA一个顾问小组投票反对这款药物的加速批准。
阿斯利康认为这款药物能成为一款潜在年销售额达20亿美元的重磅产品。奥拉帕尼可阻止一种参与细胞修补的酶，适用于有某种基因突变的患者。这款药物在治疗其它癌症方面也有良好前景，这为奥拉帕尼打开了一个相当大的市场机会。
“我们致力于研究奥拉帕尼的全部潜能，针对多种肿瘤类型正在进行大量研究，包括乳腺癌和胃癌，”阿斯利康首席医疗官Morrison称。这款治疗药物有望成为在欧洲市场上市的首款PARP抑制剂药物。
EMA表示，该机构新药专家委员会还推荐批准辉瑞的Duavive用于雌激素不足、百特国际的Rixubis用于血友病及Clinuvel的Scenesse用于光毒性。欧洲药品管理局人用医药产品委员会上市批准推荐通常会在两个月内得到欧盟委员会的支持。
阿斯利康一位发言人表示，奥拉帕尼最终批准决定预计在2015年1月做出。这家英国公司还期望能听到美国FDA于明年1月3日对这款药物批准的信息。
今年5月在成功防御辉瑞1180亿美元报价收购后，阿斯利康称该公司拥有强大独立的未来，而癌症药物是其基石。作为其防御被收购的部分措施，该英国制药商为其药物研发线制定了一套乐观的预测，并预计集团销售到2023年将会增长75%。
该公司备受关注的是其快速开发的免疫治疗试验药物，这类药物可提升人体自身免疫系统抗击癌症的能力。上个月在马德里一个癌症会议上发布的研究表明，阿斯利康在这一领域正处于一个强势地位。
On 23 October 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lynparza, 50 mg hard capsules, intended for treatment of ovarian, fallopian tube and primary peritoneal cancers in women with BRCA mutations. Lynparza was designated an orphan medicinal product on 6 December 2007. The applicant for this medicinal product is AstraZeneca AB. They may request a re-examination of the CHMP opinion, provided they notify the European Medicines Agency of their intention within 15 days of receipt of the opinion.
The active substance of Lynparza is olaparib, an inhibitor of human poly (ADP ribose) polymerase enzymes (PARP-1, PARP-2, and PARP-3) required for the efficient repair of DNA single strand breaks. In normal cells, DNA single strand breaks can also be repaired by a process known as homologous recombination repair (HRR), which requires functional BRCA1 and BRCA2 genes. However, in cancer cells without functional BRCA1 or BRCA2, single strand breaks cannot be repaired via HRR, making the cancer cells vulnerable to the inhibition of PARP by olaparib.
The main benefit of treatment with Lynparza is the improvement in progression-free survival among patients with platinum‑sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube and primary peritoneal cancers with BRCA mutations. The most common side effects are nausea, vomiting, diarrhoea, dyspepsia, fatigue, headache, dysgeusia, decreased appetite, dizziness, anaemia, neutropenia, lymphopenia, corpuscular volume elevation, and increase in creatinine.
A pharmacovigilance plan for Lynparza will be implemented as part of the marketing authorisation.
The approved indication is: "monotherapy for the maintenance treatment of adult patients with platinum‑sensitive relapsed BRCA‑mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy".
It is proposed that Lynparza be prescribed by physicians experienced in the use of anticancer medicinal products.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Lynparza and therefore recommends the granting of the marketing authorisation.
|
Name |
Lynparza |
|
INN or common name |
olaparib
|
|
Therapeutic area |
Ovarian Neoplasms |
|
Active substance |
olaparib
|
|
Date opinion adopted |
23/10/2014 |
|
Company name |
AstraZeneca AB
|
|
Status |
Positive |
|
Application type |
Initial authorisation |
Lynparza (Olaparib)
Company: AstraZeneca Pharmaceuticals LP
Application No.: 206162
Approval Date: 12/19/2014
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance
Drug Name(s) LYNPARZA
FDA Application No. (NDA) 206162
Active Ingredient(s) OLAPARIB
Company ASTRAZENECA LP
Original Approval or Tentative Approval Date December 19, 2014
Chemical Type 1 New molecular entity (NME)
Review Classification P Priority review drug
There are no Therapeutic Equivalents
Label Information
Approval History, Letters, Reviews, and Related Documents
Products on Application (NDA) #206162
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Active Ingredients
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Code
LYNPARZA OLAPARIB 50MG CAPSULE; ORAL Prescription TBD 10 TBD 11
Lynparza (Olaparib)
Company: AstraZeneca Pharmaceuticals LP
Application No.: 206162
Approval Date: 12/19/2014
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
