2011年美国35只新药获批 创7年新高
2012-01-20 MedSci MedSci原创
2011年，随着制药公司对监管部门要求提供更多安全数据作出积极回应，并全力避免FDA在最后一刻“发补”，美国获批新药数量创7年来新高，共批准35只新药(MedSci注：国内很多数据说是30只，其实不正确，35个，包括了一些成像剂），同比上一年21只有较大幅度提高。2004年共有36只新药获得批准。 小结下来，肿瘤有7个，用于孤儿病的有10个，丙肝新药2个，抗凝药物2个，用于MRSA感染1个，蝎毒
2011年，随着制药公司对监管部门要求提供更多安全数据作出积极回应，并全力避免FDA在最后一刻“发补”，美国获批新药数量创7年来新高，共批准35只新药(MedSci注：国内很多数据说是30只，其实不正确，35个，包括了一些成像剂），同比上一年21只有较大幅度提高。2004年共有36只新药获得批准。
小结下来，肿瘤有7个，用于孤儿病的有10个，丙肝新药2个，抗凝药物2个，用于MRSA感染1个，蝎毒抗血清1个，预防肾移植排斥1个，遗传性血管水肿1个，凝血障碍预防1个，其它则包括COPD治疗药物2个，4型和7型腺病毒口服活疫苗用于急性上呼吸道感染，急性冠脉综合征减少死亡，成人高血压1个，HIV-1感染相关2个，MRI对比剂1个，中重度不宁腿综合征1个，精神分裂症1个，鼻唇沟皱纹消除药物1个，头虱药物1个，癫痫1个，肺球孢子菌病迟发性过敏抗原试验1个，糖尿病药物1个。
审评更灵活
强生和葛兰素史克各有3只新药获批，2010年，没有一家制药公司的新药获批数量多于1只。
由于专利失效，2012年，至少有21只药物将失去总计115亿美元的销售收入。制药公司在2010~2011年推出的新品预计在今年仅带来40多亿美元收入。
业内一致认为，FDA的处境越来越困难，正努力改进审批效率。
2011年新批准的化合物包括百时美施贵宝的Yervoy和强生的拜瑞妥（Xarelto）。Yervoy是第一只获批用于延长晚期皮肤癌患者生命的药物。拜瑞妥是新一类抗凝血药物中获批的第二只产品，用于治疗心律不齐。
FDA还批准了由葛兰素史克和人类基因组科学公司联合开发的Benlysta，这是50年来第一只获批用于治疗狼疮的新药。
FDA药物评价与研究中心（CDER）主任珍妮特·伍德科克（Janet Woodcock）表示：“这些新药总体具有创新的特点，FDA可以更灵活地评估其疗效和风险。”
2012审评预测
2007年，美国国会进一步扩大了FDA的监督权，此前FDA对默沙东的止痛药万络和葛兰素史克的降糖药文迪雅的风险迟迟没有作出反应。自那时以来，FDA要求制药公司提交更多新药安全性和有效性数据。
葛兰素史克负责监管事务的总监保罗·胡克尔（Paul Huckle）表示，制药公司更清楚资源该投向何处，FDA在研发过程中更早介入，与制药公司进行沟通，让它们知道哪些研究资料应包含在新药申请中，以免在最后时刻发出补充材料的通知。
截至2011年11月30日，工业界向FDA提交29只新分子实体申请，2010年为22只。在2011年获批的30只新药中，19只获批时没被要求提供更多研究数据。相比之下，在2010年批准的21只新药中，监管部门只对一半新药“一步到位”地予以批准。
预计2012年新药审批步伐将受下列因素影响：美国国会对相关审批体系进行更新，制药公司继续为支付处方药审评费用。2011年工业界和FDA达成协议，将评审时间延长两个月，以便在新药接受测试期间，让双方进一步交流讨论。国会必须在10月1日通过这项协议，届时现行的《处方药申报者付费法案（PDUFA法）》将到期。
I. Priority Drugs
| Drug Name | Approval Date | Indication | Orphan Drug | Approved first in US |
PDUFA date met |
Approved on 1st cycle | Sponsor |
|---|---|---|---|---|---|---|---|
| Adcetris (brentuximab vedotin) | 8/19/11 | For treatment of Hodgkin's lymphoma and ALCL (systemic anaplastic large cell lymphoma). | X | X | X | X | Seattle Genetics Bothell, WA |
| Anascorp (Centruroides [Scorpion] Immune F(ab’)2 [Equine]) | 8/3/11 | For treatment of clinical signs of scorpion envenomation. | X | X | Rare Disease Therapeutics, Inc., Franklin,TN | ||
| Benlysta (belimumab) | 3/9/11 | To treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. | X | X | X | Human Genome Sciences, Inc., Rockville, MD co-marketed with GlaxoSmithKline, Philadelphia, PA | |
| Caprelsa (vandetanib) |
4/6/11 | To treat adult patients with metastatic (late-stage ) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms. | X | X | X | X | AstraZeneca Pharmaceuticals LP, Wilmington, DE |
| Corifact (Factor XIII Concentrate [Human]) |
2/17/11 | For routine prophylactic treatment of congenital Factor XIII deficiency. | X | X | X | CSL Bhering GmbH, King of Prussia, PA | |
| DaTscan (ioflupane i-123) |
1/14/11 | For brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian Syndrome. | X | GE Healthcare, Inc., Princeton, NJ | |||
| Dificid (fidaxomicin) | 5/27/11 | For treatment of Clostridium difficile-associated diarrhea (CDAD). | X | X | X | Optimer Pharmaceuticals Inc., San Diego, CA | |
| Firazyr (icatibant) | 8/25/11 | For treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older. | X | X | Shire Human Genetic Therapies Inc., Cambridge, MA | ||
| Halaven (eribulin mesylate |
11/15/10 | For treatment of patients with metastatic (late-stage) breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease | X | X | X | Eisai, Inc., Woodcliff Lake, NJ | |
| Incivek (telaprevir) | 5/23/11 | For treatment of certain adults with chronic hepatitis C infection. | X | X | X | Vertex Pharmaceuticals, Cambridge, MA | |
| Pradaxa (dabigatran etexilate) |
10/19/10 | To reduce the risk of stroke and blood clots in patients with abnormal heart rhythms (non-valvular atrial fibrillation). | X | X | Boehringer Ingelheim Pharm, Inc, Ridgefield, CT | ||
| Victrelis (boceprevir) | 5/13/11 | To treat certain adults with chronic hepatitis C infection. | X | X | X | Merck, Whitehouse Station, NJ | |
| Xalkori (crizotinib) and companion genetic test | 8/26/11 | To treat certain patients with late stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. | X | X | X | X | Xalkori is marketed by Pfizer, New York, NY, and the Vysis ALK Break Apart FISH Probe Kit is marketed by Abbott Molecular Inc. of Des Plaines, IL. |
| Yervoy (ipilimumab) | 3/25/11 | To treat patients with metastatic melanoma (late-stage skin cancer). | X | X | X | X | Bristol-Meyers Squibb, New York, NY |
| Zelboraf (vemuranfenib) with companion diagnostic | 8/17/11 | To treat patients with metastatic (late-stage) or unresected (cannot be removed by surgery) melanoma (skin cancer) in patients whose tumors express a gene mutation called BRAF V600E. | X | X | X | X | Zelboraf is marketed by Genentech, a member of the Roche Group, South San Francisco, CA. The cobas 4800 BRAF V600 Mutation Test is manufactured by Roche Molecular Systems, Pleasanton, CA |
| Zytiga (albiraterone acetate) | 4/28/11 | To use In combination with prednisone (a steroid), to treat patients with metastatic (late-stage) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). | X | X | X | Centocor Ortho Biotech, Inc., Horsham, PA |
II. Standard Drugs
| Drug Name | Approval Date | Indication | Orphan Drug | Approved first in US |
PDUFA date met | Approved on 1st cycle | Sponsor |
|---|---|---|---|---|---|---|---|
| Arcapta Neohaler (indacaterol inhalation powder) | 7/1/11 | For long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. | X | Novartis Pharmaceuticals Corp., East Hanover, NJ | |||
| Ardovax (Adenovirus Type 4 and Type 7 Vaccine, Live, Oral) | 3/16/11 | For active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is approved for use in military populations 17 through 50 years of age. | X | X | Teva Women’s Health, Inc., Horsham, PA | ||
| Brilinta (ticagrelor) | 7/20/11 | To reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). | X | AstraZeneca, Wilmington, DE | |||
| Daliresp (roflumilast) | 2/28/11 | To decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD). | X | Forest Pharmaceuticals St. Louis, MO | |||
| Edarbi (azilsartan medoxomil) | 2/25/11 | For treatment of high blood pressure (hypertension) in adults. | X | X | X | Takeda Pharmaceuticals North America Deerfield, IL | |
| Edurant (rilpivirine) | 5/20/11 | For treatment of HIV-1 infection in adults who have never taken HIV therapy. | X | X | X | Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc., Raritan, NJ | |
| Egrifta (tesamorelin acetate) |
11/10/10 | For reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. | X | X | Theratechnologies Inc., Montreal, Canada Marketed in US by EMD Serono, Inc., Rockland, MA | ||
| Gadavist (gadobutrol) |
3/14/11 | Contrast agent to help detect lesions in patients undergoing magnetic resonance imaging (MRI) of the central nervous system | X | X | Bayer Pharmaceuticals Wayne, NJ | ||
| Horizant (gabapentin enacarbil) | 4/6/11 | For once-daily treatment for moderate-to-severe restless legs syndrome (RLS). | X | X | GlaxoSmithKline, Research Triangle Park, NC and Xenoport, Santa Clara, CA | ||
| Latuda (lurasidone hydrochloride) |
10/28/10 | For treatment of schizophrenia in adults. | X | X | X | Sunovian Pharm, Inc Fort Lee, NJ | |
| LaViv (Azficel-T) | 6/21/11 | For improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. | X | X | Fibrocell Technologies, Inc., Exton, PA | ||
| Natroba (spinosad) | 1/18/11 | For treatment of head lice infestation in patients ages 4 years and older. | X | X | ParaPRO, LLC, Carmel, IN | ||
| Nulojix (belatacept) | 6/15/11 | To prevent organ rejection in adult patients who have had a kidney transplant, in combination with other immunosuppressants. | X | X | X | Bristol-Meyers Squibb, Princeton, NJ | |
| Potiga (ezogabine) | 6/10/11 | For use as an add-on medication to treat seizures associated with epilepsy in adults. | X | Developed by Valeant Pharmaceuticals North America, Durham, NC Marketed by GlaxoSmithKline, Research Triangle Park, NC. | |||
| Spherusol (Coccidioides immitis Spherule-Derived Skin Test Antigen) | 7/29/11 | For detection of delayed type hypersensitivity to C. immitis in individuals, 18-64 years of age, with a history of pulmonary coccidioidomycosis. | X | X | X | Allermed Laboratories, Inc., San Diego, CA | |
| Teflaro (ceftaroline fosamil) | 10/29/10 | For treatment of acute bacterial skin and skin structure infections and community acquired bacterial pneumonia. | X | X | X | Cerexa, Inc., Oakland, CA | |
| Tradjenta (linagliptin) | 5/2/11 | For use as an adjunct to diet and exercise to improve glycemic (blood sugar) control in adults with type 2 diabetes. | X | X | X | Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT and Eli Lilly Co., Indianapolis, IN | |
| Viibryd (vilazodone hydrochloride) | 1/21/11 | For treatment of major depressive disorder in adults. | X | X | X | PGxHealth, New Haven, CT | |
| Xarelto (rivaroxaban) | 7/1/11 | To reduce the risk of blood clots, deep vein thrombosis(DVT), and pulmonary embolism (PE) following knee or hip replacement surgery. | X | Janssen Pharmaceuticals, Inc., a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Raritan, NJ. |
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