If the agency says affirmative, a serious new weight loss drug might hit the market this year. A high-dose formulation of liraglutide, the popular polygenic disorder drug from Novo Nordisk, melts up to ten p.c of body mass, studies show.
Liraglutide, obtainable in one.2 mg and 1.8 mg doses as Victoza, is already a large success for Novo Nordisk. the corporate has currently filed with the agency seeking approval for a three.0 mg dose once studies found major weight loss edges (in conjunction with diet and exercise.)
In clinical trials, liraglutide helped those taking it lose five to ten p.c of their body mass, consistent with analysis printed within the International Journal of fat. And whereas this study checked out folks with polygenic disorder, a previous study printed within the Lancet tested the drug in non-diabetics and located equally spectacular weight loss.
In late December, Novo Nordisk filed 2 submissions for liraglutide, a brand new drug application (NDA) with the agency, and a promoting Authorization Application (MAA) with the eu Medicines Agency, consistent with Drug Discovery & Development.
But some of us might not ought to wait even that long. In Feb, Novo Nordisk created the weird move of targeting Mexico for associate initial approval of high-dose liraglutide. et al might not wait at all; whereas the studies warn against mistreatment liraglutide “off-label” for weight loss, it looks bound that patients can look for to use Victoza for that purpose.
Liraglutide works by mimicking a endocrine called GLP-1, that slows digestion and stimulates the body’s natural production of hormone. Victoza has been terribly prosperous for Novo Nordisk, with sales jumping fifty eight p.c in 2012, and mounting a further fourteen p.c within the third quarter of 2013.
Experts square measure sticking out that liraglutide would have blockbuster potential as a weight loss application as a result of the marketplace for weight loss is thus massive.
The study in non-diabetics, conducted by Arne Astrup of the University of Danish capital, tested four totally different doses of liraglutide: (1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg) against placebo and another drug, Orlistat and located that individuals taking the very best dose of liraglutide lost a median of virtually sixteen pounds. folks taking the lower doses conjointly lost weight, between ten pounds with one.2 mg and thirteen pounds at a pair of.4 mg.
Just as exciting, liraglutide was found to cut back pre-diabetes, lower vital sign, and even facilitate scale back sleep disorder. the foremost common aspect effects from liraglutide were mild; some participants toughened nausea,vomiting and looseness of the bowels once they initial started taking the drug however in most cases the issues subsided over time.
However, there are additional serious safety concerns; presently the agency is investigation the whole category of GLP-1 medicine to examine if they raise the danger of redness. Victoza conjointly carries a warning that animal studies found it caused thyroid tumors, each benign and cancerous, in mice, which it’s “not known” if it might carry constant risk for humans.
And then there’s the very fact that liraglutide is run as a daily injection, which is able to probably prove a barrier for several folks, particularly given the supply of oral weight loss medicine like Qsymia and Belviq.
A Class of Potential Weight Loss Cures
Liraglutide belongs to a category of medication called incretin mimetics, all of which can prove to be potential weight loss cures.
AstraZeneca’s evenatide (Byetta, Bydureon) the opposite GLP-1 analog on the market, has conjointly been found to help weight loss, and also the fat community is taking notice. Weight loss bulletin boards square measure a-buzz with queries, and health specialists like mayonnaise Clinic square measure setting out to weigh in on the difficulty.
Meanwhile, additional GLP-1 analogs return down the pipeline. simply a couple of weeks agone the agency approved albiglutide (Tanzeum), GlaxoSmithKline’s GLP-1 challenger, that solely should be injected once-a-week.
And the agency is presently reviewing Eli Lilly‘s GLP-1 analog, dulaglutide, that seems to be as promising for weight loss as liraglutide, and conjointly has once-a-week dose. Eli Lilly hopes to own dulaglutide in pharmacies by the tip of 2014. Pharmacists project weight loss edges could also be even as necessary as polygenic disorder management in determinative that GLP-1 drug is most prosperous.
Sanofi’s GLP-1 analog Lyxumi launched in Europe in late 2013, however the corporate recently withdrew it’s application for agency approval within the U.S. unfinished associate investigation into the drug’s vessel safety.
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