New Drug Approvals

Home » NICE

Category Archives: NICE


Blog Stats

  • 4,238,473 hits

Flag and hits

Flag Counter

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,801 other subscribers
Follow New Drug Approvals on



Recent Posts

Flag Counter


Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,801 other subscribers


DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA, ROW2TECH, CLEANCHEM LABS as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

Personal Links

Verified Services

View Full Profile →



Flag Counter

Xolair gains final NICE approval

NICE is recommending Novartis’ asthma drug Xolair as a cost effective treatment for young children and adults with a severe form of the condition in England.

Novartis’ Xolair (omalizumab) is now recommended as an option for treating severe, persistent confirmed allergic immunoglobulin E (IgE)-mediated asthma in people aged six years and older.


Omalizumab (trade name Xolair, Roche/Genentech and Novartis) is a humanized antibody approved for patients 12 years and older with moderate to severe allergic asthmain the United States and with severe, persistent allergic asthma in many other countries. It has also been approved for pediatric patients 6 to 11 years old with severe, persistent allergic asthma in the European Union. Omalizumab’s cost is high, ranging from $6,000 to $24,000 a year and hence omalizumab is mainly prescribed for patients with severe, persistent asthma, which cannot be controlled even with high doses of corticosteroids.

Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. Unlike an ordinary anti-IgE antibody, omalizumab does not bind to IgE that is already bound by the high affinity IgE receptor (FcεRI) on the surface of mast cells,basophils, and antigen-presenting dendritic cells. IgE is commonly involved in type I hypersensitivity, which manifests the most prevalent allergic diseases. It has been estimated that as high as 20 to 40% of the populations who live a western lifestyle in economically advanced countries are affected by allergy and seek medical help.[1] While allergy occurs more frequently in individuals with higher serum IgE levels, such a correlation is only statistical and not absolute. Some allergic individuals have very low serum IgE, and some people with very high IgE have no allergic problems.

Xolair received approval by the U.S. Food and Drug Administration (FDA) in 2003 for treating patients 12 years and older with moderate to severe allergic asthma. It has also received approval in many other countries for treating patients 12 years and older with severe, persistent allergic asthma. Xolair was approved by the European Union in 2009 for treating patients 6 to 12 years old with severe, persistent allergic asthma. Thus, the primary use of Xolair is for patients mostly with severe, persistent allergic asthma, uncontrollable with oral or injectable corticosteroids.[2] The efficacy is more evident among severe asthmatics than among those with moderately severe disease. The response rates among treated severe “allergic” asthma patients are 60-80% or higher, probably depending on the patient screening procedures used by the various clinical groups of different specialties. Because 30-40% of adult asthma cases are not related to allergy and unresponsive to Xolair, a reliable way to identify treatable patients has been a subject of considerable research interest. The primary benefits for the responding patients are reduced numbers of exacerbations, improved lung function, reduced numbers of emergency visits to the doctors, reduced days of hospitalization, and increased quality of life measurements. The other major benefit is that most responding patients can reduce or spare entirely the use of corticosteroids, which cause multiple serious side effects, when used at high doses for extended periods.

Due to the requirement for long-term administration and hence the high cost of a Xolair treatment regimen, and to the concern over long-term safety, Xolair treatment is not yet very common, especially in developing countries where medical funds are relatively scarce. Another barrier to Xolair’s wide use is its injectable dosage form, which requires the patient to visit a physician’s office or clinic every 2 to 4 weeks during treatment. In August 2010, the National Institute for Clinical Excellence (NICE) in the United Kingdom ruled that Xolair should not be prescribed on the National Health Service (NHS) to children under 12, causing widespread condemnation from asthma charities.[3] NICE concluded that the high costs of the compound, over £250 per vial, did not represent a sufficiently high increase in quality of life. Additionally, as IgE could be a natural defense against parasitic diseases, treatment is usually not recommended when living in environments where the presence of parasites is common.

The website reveals that 102 clinical trials on omalizumab on various clinical indications have been finished or are in progress as of June 23, 2012. Among those more than 70 are multi-center, placebo-controlled phase II or III trials.[4] The tested indications are in the areas of allergic asthma, perennial and seasonal allergic rhinitis, peanut allergy, latex allergy, atopic dermatitis,chronic urticaria, idiopathic anaphylaxis, mastocytosis, eosinophilic gastroenteritis, nasal polyposis, and others. The relatively recent clinical trial results, which indicate that omalizumab has excellent effects on patients with recalcitrant, antihistamine-resistant chronic idiopathic urticaria, including those cases of autoimmune cause,[5][6] have generated much excitement among dermatologists as well as patients affected by chronic urticaria. Omalizumab has also been studied in combination with allergen-based specificimmunotherapy (allergy shots) for the purpose of reducing anaphylactic reactions when receiving allergen immunizations and of accelerating immunization schedule and dosing, so as to achieve therapeutic effects in shorter treatment periods and in broader patient populations.[7][8][9]

While data from additional clinical trials are required for omalizumab to be reviewed by governmental regulatory bodies for approval for any of the new indications, the data from finished trials thus far indicate that omalizumab is efficacious and safe for treating various IgE-mediated allergic or non-allergic diseases

  2.  Davydov L (January 2005). “Omalizumab (Xolair) for treatment of asthma”. Am Fam Physician 71 (2): 341–2. PMID 15686303.
  3.  “Asthma drug ruling ‘nonsensical'”BBC News. August 12, 2010.
  5.  Saini S, Rosen KE, Hsieh HJ, Wong DA, Conner E, Kaplan A, Spector S, Maurer M (September 2011). “A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria”. J. Allergy Clin. Immunol. 128 (3): 567–73.e1. doi:10.1016/j.jaci.2011.06.010PMID 21762974.
  6.  Kaplan AP, Joseph K, Maykut RJ, Geba GP, Zeldin RK (September 2008). “Treatment of chronic autoimmune urticaria with omalizumab”. J. Allergy Clin. Immunol. 122 (3): 569–73. doi:10.1016/j.jaci.2008.07.006PMID 18774392.
  7.  Casale TB, Busse WW, Kline JN, Ballas ZK, Moss MH, Townley RG, Mokhtarani M, Seyfert-Margolis V, Asare A, Bateman K, Deniz Y (January 2006). “Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis”. J. Allergy Clin. Immunol. 117 (1): 134–40. doi:10.1016/j.jaci.2005.09.036PMID 16387596.
  8.  Kopp MV, Hamelmann E, Zielen S, Kamin W, Bergmann KC, Sieder C, Stenglein S, Seyfried S, Wahn U; DUAL study group (October 2008). “Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma”. Clin Exp Allergy 39 (2): 271–9. doi:10.1111/j.1365-2222.2008.03121.x.PMID 19016798.
  9.  Massanari M, Nelson H, Casale T, Busse W, Kianifard F, Geba GP, Zeldin RK (February 2010). “Effect of pretreatment with omalizumab on the tolerability of specific immunotherapy in allergic asthma”. J. Allergy Clin. Immunol. 125 (2): 383–9.doi:10.1016/j.jaci.2009.11.022PMID 20159249.

NICE has given a provisional green light for Bayer’s blood thinner Xarelto for help patients with thrombotic events

Xarelto gains NICE thumbs up for DVT licence

NICE has given a provisional green light for Bayer’s blood thinner Xarelto for help patients with thrombotic events


National Institute for Health and Care Excellence

Developing a series of national clinical guidelines to secure consistent, high quality, evidence based care for patients using the National Health Service in

April 22, 2013





Rivaroxaban (BAY 59-7939) is an oral anticoagulant invented and manufactured by Bayer; in a number of countries it is marketed as Xarelto. In the United States, it is marketed by Janssen Pharmaceutica. It is the first available orally active direct factor Xa inhibitor. Rivaroxaban is well absorbed from the gut and maximum inhibition of factor Xa occurs four hours after a dose. The effects lasts 8–12 hours, but factor Xa activity does not return to normal within 24 hours so once-daily dosing is possible. There is no specific way to reverse the anticoagulant effect of rivaroxaban in the event of a major bleeding event, unlike warfarin

In September 2008, Health Canada granted marketing authorization for rivaroxaban as one 10 mg tablet taken once daily for the prevention of venous thromboembolism (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery.


In September 2008, the European Commission granted marketing authorization of rivaroxaban for the prevention of venous thromboembolism in adult patients undergoing elective hip and knee replacement surgery. In December 2011 rivaroxaban has been approved by the European Commission for use in two new indications: prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors and treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.


On July 1, 2011, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery. On November 4, 2011, the U.S. FDA approved rivaroxaban for stroke prophylaxis in patients with non-valvular atrial fibrillation. On November 2, 2012, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for the treatment of patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) and for long-term treatment to prevent recurrence.


%d bloggers like this: