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NovoEight (turoctocog alfa) Receives Approval from the FDA

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Bagsværd, Denmark, 16 October 2013 – Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for recombinant coagulation factor VIII, Novoeight.

The FDA approved Novoeight for use in adults and children with hemophilia A for:

  • Control and prevention of bleeding
  • Perioperative management
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

http://www.drugs.com/newdrugs/novoeight-turoctocog-alfa-receives-approval-fda-3931.html

turoctocog alfa (NN7008)

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Novo Nordisk recently announced the company has submitted the regulatory application to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its turoctocog alfa (NN7008) for prevention and treatment of bleeding in people with hemophilia A.

The decision for submission was based on results from the guardian trials consisting of over 200 people with hemophilia A, making guardian the largest pre-registration clinical trial program for hemophilia A. The trials contained previously treated adults and children with severe hemophilia A.

Turoctocog alfa is a third-generation recombinant coagulation factor VIII drug, designed to increase reliability, safety and portability for patients with hemophilia A.

“We are very excited about having reached this goal. Turoctocog alfa represents a new treatment alternative for people with hemophilia A and is one of the first important outcomes of the hemophilia research strategy we embarked upon in 2006,” Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk said in a news release.

The company said that in the next few months, it plans to submit applications for regulatory approval in other countries as well.

Hemophilia A is estimated to affect 500,000 people worldwide, and is extremely under-diagnosed in developing countries.

ema clip

On 19 September 2013, the Committee for Medicinal Products for Human Use(CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product NovoEight 250, 500, 100, 1500, 2000 or 3000 IU, powder and solvent for solution for injection, intended for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).The applicant for this medicinal product is Novonordisk. It may request are-examination of the CHMP opinion, provided it notifies the European Medicines Agency in writing of its intention within 15 days of receipt of the opinion.

The active substance of NovoEight is turoctocog alfa, human recombinant factor VIII that enables the temporary substitution of the endogenous coagulation factor VIII in haemophilia A patients. The benefits with NovoEight are its ability to prevent and treat the bleeds in previously treated patients with severe haemophilia A. The most common side effects are increase in hepatic enzymes and injection-site reaction.

A pharmacovigilance plan for NovoEight will be implemented as part of themarketing authorisation.

The approved indication is:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).

It is proposed that NovoEight be prescribed by physicians experienced in the treatment of haemophilia A. It is proposed that treatment should be initiated under the supervision of a doctor experienced in the treatment of haemophilia.

Detailed recommendations for the use of this product will be described in thesummary 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 NovoEight and therefore recommends the granting of the marketing authorisation.


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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

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 GLENMARK LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 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, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, 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 30 PLUS year tenure till date June 2021, 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 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 33 lakh plus views on New Drug Approvals Blog in 233 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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