New Blockbuster Drugs: FDA/EMA Approved in 2011
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New Drug Approvals FDA/EMA 2011
A live real time updated list of new drugs approved in the US and Europe is provided. Only selected new drugs with a blockbuster ;potential (to reach annual sales of >1 billion dollars) are listed. Only new molecular/chemical entities (NME/NCE) are included. Approvals of Generics, new formulations or additional indications are not covered.
The US FDA has approved 26 new drugs by the end of August this year compared to only 21 NME approved in 2010. FDA approved 6 life saving cancer drugs, Yervoy and Zelboraf for advanced melanoma and Xalkori for NSCLC. It approved 2 new groundbreaking drugs for Hepatitis C. The current year is trending to a recent record for new drug approvals in the 35-40 range.
The EMA in Europe has 18 new drugs approved in the first 8 months vs only 14 approved last year . There is a backlog of over 40 drugs recommended for approval by the CHMP. A live updated review of new NME drug approvals, rejections and market withdrawals by the EMA in the year 2011 is provided.
Key words: FDA, EMA, NME, NCE, Approvals, Regulatory, Blockbuster Drugs, Zelboraf. Yervoy, Benlysta, Incivek, Victrelis, Edarbi, Viibryd, Daliresp, Zytiga, Tradjenta, Arcapta, Xarelto, Brilinta, Adcetris, Gilenya, Trobalt, Bydureon, Xgeva, Jevtana, Halaven, Teysuno.
The US FDA has approved 26 new drugs by the end of August this year compared to only 21 NME approved in 2010. FDA approved 6 life saving cancer drugs, Yervoy and Zelboraf for advanced melanoma and Xalkori for NSCLC. It approved 2 new groundbreaking drugs for Hepatitis C. The current year is trending to a recent record for new drug approvals in the 35-40 range.
The EMA in Europe has 18 new drugs approved in the first 8 months vs only 14 approved last year . There is a backlog of over 40 drugs recommended for approval by the CHMP. A live updated review of new NME drug approvals, rejections and market withdrawals by the EMA in the year 2011 is provided.
Key words: FDA, EMA, NME, NCE, Approvals, Regulatory, Blockbuster Drugs, Zelboraf. Yervoy, Benlysta, Incivek, Victrelis, Edarbi, Viibryd, Daliresp, Zytiga, Tradjenta, Arcapta, Xarelto, Brilinta, Adcetris, Gilenya, Trobalt, Bydureon, Xgeva, Jevtana, Halaven, Teysuno.
Table of Contents
- FDA/EMA New Drug Approvals 2011
- Human chromosomes Wellcome Trust Image
- Video Module
- Top ten drugs 2011
- Newly Approved Drug Sales 2011
- New drug approvals FDA/EMA 2011
- Blockbuster New Drugs
- Krishan Maggon Link List
- RSS: Zelboraf(R) (Vemurafenib, Roche) for advanced metastatic melanoma
- New Guestbook Comments
- Amazon Books and Monographs
- Guestbook Comments
- Give your opinion
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FDA/EMA New Drug Approvals 2011
Indications & companies
FDA NME Approvals in 2011 Limited to new innovative drugs and companies. Generics, new indications for approved drugs and new formulations are not covered.26 NME approved so far, 3 monoclonal antibodies, 3 tyrosine kinase inhibitors
6 new drugs for cancer
Blood clot Prevention
Xarelto® (Rivaroxaban, Bayer, J&J); new class of blood clot agent, delayed due to 2 CRL in 2009 and 2010, approved in July 2011.
Brilinta® (Ticagrelor, AZN, BMS) for prevention of athereoscelrosis. Class II -6 month review: Approved20 July.
Hypertension
Edarbi® (Azilsartan, Takeda) new angiotensin II receptor blocker for Hypertension, most potent marketed ARB
Cancer
Hodgkin's Lymphoma and ALCL
Adcetris® (Brentuximab vedotin, Seattle Genetics ) for refractory/relapsing Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma ALCL, priority review and orphan drug. PDUFA 30 August, ODAC panel meeting 14 July. The ODAC expert panel recommends accelerated approval by 10 to 0 votes. First NDA for a mab drug conjugate, approved 18 August.
Thyroid Cancer
Zictifa® (Vendetanib) for thyroid cancer Astra Zeneca AZN by Jan 7. Extended by 3 months to 7 April , likely under REMS. Approved 6 April
Caprelsa® ( Vendetanib, Astra Zeneca) First drug approved for medullar Thyroid cancer, orphan,p, REMS.
Prostate Cancer
Zytiga® (Abiraterone, J&J) late-stage prostate cancer 20 June, approved 28 April
Metastatic Melanoma
Yervoy® (Ipilimumab) for metastatic melanoma BMY by march 26. Approved 25 March. REMS
Immune Diseases
Vemurafenib (Zelboraf®, PLX 4032, RG 7204, Roche, Plexxikon) for advanced melanoma 11 May, PDUFA 11 November? Approved 17 August.
Lung Cancer
Xalkori® (Crizotinib, Pfizer) anaplastic lymphoma kinase inhibitor, ALK positive advanced NSCLC, orphan drug, fast track priority review. Approved 26 August.
Lupus, SLE
Benlysta® (Belimumab, HGS, GSK) for Lupus, Approved. in March under REMS
COPD
Daxas® , Daliresp® (Roflumilast, Forest) for COPD 1Q2011. Approved
Arcapta Neohaler® (Indacaterol, Novartis) for COPD. Expert panel discussion 8 March. Review date extended from 1 April to 1 July. Lower dose approved.
Depression
Viibryd® (Viladozone, Forest, MerckAG) for depression
Restless Legs
Horizant® (Gabapentin enacarbil, GSK, Xenoport) for restless leg syndrome.. Approved 6 April.
AIDS/HIV
Edurant® (Rilpiivirine, J&J) for HIV
Hepatitis C
Victrelis® (Bosepravir, Merck) for Hepatitis C.15 May. Approved
Incivek® (Telapravir, Vertex, GSK, Mitsubishi Tanabe) for Hepatitis C. 23 May. Approved.
Fecal Incontinence
Solesta® (Oceana, QMed) fecal incontinence, panel unanimous yes 5-0, Approved 27 May.
Diabetes
Tradjenta® (Linagliptin, Lilly, Boehringer Ingelheim) for Type 2 Diabetes
Epilepsy
Potiga® (Ezogabine, GSK, Valeant) for epilepsy, under REMS, DEA controlled substance.
EMA New Drug Approvals 2011
Ticagrelor (Brilique®, Possia®, Astra Zeneca) platelets aggregate inhibitor for prevention of arthero-thrombotic events (clot formation, platelets aggregation)
Apixaban (Eliquis®, BMS) oral anticoagulant, factor Xa inhibitor for Venous Thromboembolic Events (VTE)
Fingolimod (Gilenya®, Novartis) the first oral drug for Multiple Scelrosis
Paliperidone (Xeplion®, J&J) for Schizophrenia
Belimumab (Benlysta®, HGS, GSK) for Lupus
Retigabine(Trobalt®, GSK, Valeant) for seizures epilepsy
Boceprevir (Victrelis®, Merck, Roche) for hepatitis C
Extenatide(Bydureon®, Lilly, Amylin, Alkermes) for Type 2 Diabetes
Linagliptin (Trajenta®, Lilly, Boehringer Ingelheim) for Type 2 Diabetes
Denosumab (Xgeva®, Amgen) mab RANKL for prevention of bone complications in cancer patients
Ipilimumab (Yervoy®, BMS) a CTLA4 mab for metastatic melanoma
Arbiraterone (Zytiga®, J&J) for prostate cancer
Carbazitaxel (Jevtana®, Sanofi Aventis) for prostate cancer
Eribulin (Halaven®, Eisai) for breast cancer
Tegafur, gimeracil, oteracil (Teysuno®, Taiho) for advanced gastric cancer
Vibativ® (Telavancin, Astellas, Theravance) for nosocomial pneumonia due to gram positive MRSA Infections.
Human chromosomes Wellcome Trust Image
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Top ten drugs 2011
Global top selling human medicines
Newly Approved Drug Sales 2011
Blockbuster New drugs
Telaprevir (Incivek®, Incivo®, Vertex, J&J ) becomes the first blockbuster of the newly approved drugs due to strong unmet demand from Hepatitis C patients and its higher cure rates.
The projected 2011 sales of top newly approved drugs ( in $ millions)
Incivek 1000
Affinitor 430
Gilenya 350
Yervoy 350
Xgeva 340
Prolia 170
Victrelis 150
Benlysta 50
Fampyra 10
European EPARs of Newly Approved Drugs
The projected 2011 sales of top newly approved drugs ( in $ millions)
Incivek 1000
Affinitor 430
Gilenya 350
Yervoy 350
Xgeva 340
Prolia 170
Victrelis 150
Benlysta 50
Fampyra 10
European EPARs of Newly Approved Drugs
New drug approvals FDA/EMA 2011
Newly approved Medicines in Europe/US
Newly approved and market launch of medicines
Blockbuster New Drugs
FDA & EMA Approvals 2011
Krishan Maggon Link List
KKM
Direct links are provided to the regulatory bodies FDA and EMA to some of the newly approved drugs.
- Top Ten/Twenty Best Selling Drugs 2010 - a knol by Krishan Maggon
- The global pharmaceutical markets expanded to $850 billion in 2010. Biotechnology and generic industry once again increased their share of the global pie to $140 billion and $ 120 billion respectively. Biosimilar sales outside USA crossed 1 billion dollars. In spite of increased generic and new arrival competition, Lipitor retained its top position as the best selling global drug brand inspite of sales decline and competition from genric statins. It was followed by Plavix and Remicade. Plavix became the second drug to have annual sales of over 9 billion dollar. Six biologics made the top 12 and eight biologics made the top twenty grades as the best selling global drug brands. Remicade emerged as the best selling biologics and mab in 2010.
- Top Ten/Twenty Best Selling Drugs 2009 - a knol by Krishan Maggon
- The global pharmaceutical markets expanded to $810 billion in 2009. Biotechnology and generic industry once again increased their share of the global pie to $130 billion and $ 90 billion respectively. In spite of increased generic and new arrival competition, Lipitor retained its top position as the best selling global drug brand inspite of sales decline and competition from genric statins. It was followed by Plavix and Enbrel. Plavix became the second drug to have annual sales of over 9 billion dollar. Five biologics made the top ten and eight biologics made the top twenty grades as the best selling global drugs.
- Global Pharmaceutical Market Review & World Top Ten/Twenty Drugs 2008 - a knol by Krishan Maggon
- The global pharmaceutical markets expanded to $770 billion in 2008. Biotechnology and generic industry once again increased their share of the global pie to $120 billion and $ 80 billion respectively. Lipitor retained its top position as the best selling global drug. It was followed by Plavix and Enbrel. Four biologics made the top ten and seven biologics made the top twenty grades as the best selling global drugs.
- New Drug Approvals FDA/EMA 2010 - a knol by Krishan Maggon
- The FDA approved 21 new drugs in 2010 compared to 25 in 2009 and 21 NME approved in 2008. The number of new drugs approved has remained in the 20- 25 range by the FDA and EMA each during the past 4 years. The number of new drugs approved by the EMA was only 14 a historic low in recent years. Thus despite talks of increased R&D productivity and higher R&D spending, number of new drugs clearing regulatory hurdles has remained in the 20-25 range during the past few years. It is unlikely to change in the next few years. Biologics (monoclonal antibodies, vaccines) accounted for half of the new approvals in 2010. Vaccines and monoclonal antibodies account for a major share of newly approved biologics.
- New Drug Approvals USA ( FDA 2009 ) - a knol by Krishan Maggon
- The number of 25 new drugs approved by the FDA in 2009 was slightly better than 22 and 18 new drugs approved in 2008 and 2007...
- High Priced Prescription Drugs - a knol by Krishan Maggon
- This is a discussion forum to debate the high cost of prescription drugs. Patient co-payments can range from $3000-60,000 per...
- New Drug Approvals Europe ( EMA 2009 ) - a knol by Krishan Maggon
- The number of 50 new drugs approved by the EMA in Europe was 30% higher than the 38 new drugs approved by the FDA in 2009....
- Top Ten Monoclonal Antibodies 2010 - a knol by Krishan Maggon
- Despite economic downturn, the growth in the mAbs showed no sign of slowing down. The global monoclonal antibody market...
- Boceprevir (Victrelis%u2122) & Telaprevir (Incivek®, Incivo® ) Hepatitis C : FDA/EMA Review & Approval - a knol by Krishan Maggon
- Incivek® ,Incivo® (telaprevir, Vertex, J&J) was approved by the FDA on 23 May, 2011 (PDUFA date). The labeling gives...
- Ipilimumab (Yervoy®, BMS) Review: A Cancer Breakthrough? - a knol by Krishan Maggon
- FDA has approved Yervoy (ipilimumab, BMS) under REMS for the treatment of metastatic melanoma. It was approved in EU by the...
- Vemurafenib (Zelboraf®, PLX 4032) Melanoma: FDA Review & Approval - a knol by Krishan Maggon
- The FDA approved Zelboraf on 17 August 20111 for the treatment of late stage metastatic melanoma. EMA approval is expected...
- Belimumab (Benlysta, HGSI, GSK) Lupus Review - a knol by Krishan Maggon
- No new drug has been approved to treat Lupus during the past 50 years. Belimumab is one of the rare new biologics to complete...
- Global Vaccine Market 2010 - a knol by Krishan Maggon
- The global vaccines sales in 2010 were $ 28 billion as compared to $26 billion in 2009, $24 billion in 2008 and $18.5 billion...
- Denosumab (Xgeva, Amgen) Cancer : FDA Review & Approval - a knol by Krishan Maggon
- Denosumab is a breakthrough fully human monoclonal antibody approved by both the FDA and EMA in 2010. It had been fast...
- Xalkori® (Crizotinib) Lung Cancer: FDA Review & Approval - a knol by Krishan Maggon
- Xalkori (crizotinib, Pfizer) is a good example of fast track targeted drug development. It was approved by the FDA within 6...
- New Drug Approvals EMA 2011 - a knol by Krishan Maggon
- The current year is trending to a recent record for new drug approvals in Europe as 18 new drugs approved in the first 8...
- Denosumab (Prolia, Amgen) FDA Review & Approval - a knol by Krishan Maggon
- Denosumab is a breakthrough fully human monoclonal antibody approved by both the FDA and EMA in 2010. It had been fast...
- Tyrosine Kinase Inhibitors R&D Review 2011 - a knol by Krishan Maggon
- The FDA approval of 3 tyrosine kinase inhibitors (TKI) in 2011 (Caprelsa, Zelboraf and Xalkori) has given a big push to the...
- R&D Productivity Pharma Biotech Industry 2011 - a knol by Krishan Maggon
- After years of stagnation and declining new drug approvals and increasing R&D budgets, it seems that 2011 is going to reverse...
RSS: Zelboraf(R) (Vemurafenib, Roche) for advanced metastatic melanoma
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Table of Contents
- FDA/EMA New Drug Approvals 2011
- Human chromosomes Wellcome Trust Image
- Video Module
- Top ten drugs 2011
- Newly Approved Drug Sales 2011
- New drug approvals FDA/EMA 2011
- Blockbuster New Drugs
- Krishan Maggon Link List
- RSS: Zelboraf(R) (Vemurafenib, Roche) for advanced metastatic melanoma
- New Guestbook Comments
- Amazon Books and Monographs
- Guestbook Comments
- Give your opinion
- Guestbook Comments
- Amazon
- Google Health News
- Guestbook Comments
- Flickr Photos
- Video Module
- Poll Module
- Twitter Follow
- Netflix
- Duel Debate Module
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