New Drug Approvals

Home » Uncategorized » Novo’s long-acting insulin, name-insulin degludec , Tresiba makes way to UK

Novo’s long-acting insulin, name-insulin degludec , Tresiba makes way to UK

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Categories

Recent Posts

Blog Stats

  • 3,899,405 hits

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

Join 2,719 other followers

add to any

Share

diabetes-insulin

Degludec MoleculeDEGLUDEC

B29N(epsilon)-omega-carboxypentadecanoyl-gamma-L-glutamyl desB30 human insulin

Insulin degludec is a ultralong-acting basal insulin analogue being developed by Novo Nordisk under the brand name Tresiba. It is injected subcutaneously three-times a week to help control the blood sugar level of those with diabetes. It has a duration of action that lasts up to 40 hours, unlike the 18 to 26 hours provided by current marketed long-acting insulins such as insulin glargine and insulin detemir.

Insulin degludec is a modified insulin that has one single amino acid deleted in comparison to human insulin, and is conjugated to hexadecanedioic acid via gamma-L-glutamyl spacer at the amino acid lysine at position B29.

MARCH 05, 2013

Patients with diabetes in the UK can now get access to a new treatment option following the roll out of Novo Nordisk’s ultra-long-acting insulin Tresiba in the country, marking its first launch in Europe.

The European Commission issued a green light for the drug – as well as sister product Ryzodeg (insulin degludec/insulin aspart) – for the treatment of diabetes in adults back in January.

Approval came on the back of studies comparing Tresiba to Sanofi’s blockbuster Lantus (insulin glargine), in which Novo’s drug demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia, which is particularly important as patients are less aware of the symptoms, while successfully achieving equivalent reductions in HbA1c.

In fact, clinical data showed a 25% reduction in nocturnal hypoglycaemia for patients with type I diabetes taking Tresiba, while for insulin-naiive patients with Type II diabetes there was a 36% reduction compared to Lantus, the company said, although noting hypoglycaemia is still the most common side effect linked with its drug.

“With our current insulin treatments, it is important for people with diabetes to take their long-acting insulin at around the same time each day. However, the pharmacokinetics of insulin degludec mean that, on occasions when this is not possible, people with diabetes can alter the time they take their insulin without compromising their diabetes control or putting themselves at increased risk of hypoglycaemia,” commented Professor Richard Holt, Professor in Diabetes and Endocrinology at the University of Southampton.

“Good control of diabetes is essential to reduce the risk of long-term complications, so flexibility, when needed, is important,” he added.

Competitive edge?

In addition, its associated cut in the risk of nocturnal hypoglycaemia could give the drug another competitive edge, given that almost 50% of severe hypoglycaemic episodes – which have a significant impact not only on the patient but on the economy – occur at night.

The estimated UK cost for severe hypoglycaemia hit £30.4 million and £41.8 million for moderate hypoglycaemia in 2010/11, and each severe hypoglycaemic episode involving hospitalisation costs the NHS an estimated £2,153 per person.

The drug does come with a weighty price-tag, costing £72.00 per pack of 5 x 3 ml U100 FlexTouch pens, compared to the £41.50 per pack (5 x 3ml pre-filled pens) of Lantus. But a spokesperson for Novo stressed to PharmaTimes UK News that its price “reflects the clinical benefits and innovation that insulin degludec brings to patients”.

The National Institute for Health and Clinical Excellence will include Tresba its updated NICE Clinical Guidelines on diabetes, which are expected in 2014, the spokesperson confirmed.

Last month Novo was dealt a huge blow when US regulators knocked back Tresiba, after being reluctant to approve the drug without additional data on its cardiovascular effects.

The move came as somewhat of a surprise, given that advisers to the US Food and Drug Administration actually supported its approval, albeit with the proviso that a post-marketing cardiovascular outcomes trial be carried out.

Novo's long-acting insulin hits UK shores


8 Comments

  1. medchemnintabelle says:

    Reblogged this on MedCheminAustralia.

  2. makson says:

    is this insulin is available in India?

  3. DrSCGupta says:

    How to adjust doses of Degludec

  4. Candra says:

    I seriously love your website.. Excellent colors & theme.

    Did you build this web site yourself? Please reply back as I’m
    planning to create my own site and would like to learn where you got this from or just what the theme is called.
    Thank you!

  5. Gulshan Kumar Talwar says:

    Can I get one Rhyzodeg Inj on payment basis. Am staying in C 118 Saraswati Kunj GHS 25, Patparganj, Delhi 110092. Max Hospital has prescribed this. Dr S Bhattacharya.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

DR ANTHONY CRASTO

Follow New Drug Approvals on WordPress.com

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

Join 2,719 other followers

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

Personal Links

View Full Profile →

TWITTER

bloglovin

Follow my blog with Bloglovin The title of your home page You could put your verification ID in a comment Or, in its own meta tag Or, as one of your keywords Your content is here. The verification ID will NOT be detected if you put it here.
%d bloggers like this: