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Post by biotec on Mar 26, 2014 21:20:11 GMT -5
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Post by babaoriley on Mar 26, 2014 22:48:16 GMT -5
Interesting, "an opinion from the FDA is expected in mid-April." What's that mean?
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Post by biotec on Mar 27, 2014 7:27:02 GMT -5
IDK bab, Seeing if anyone here has heard of this drug? A friend told me about it last month, Didn't think it was that far up in the FDA. EU already approved it, Almost like its top secret or something.This could be alot of competition for the type 2 market
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Post by savzak on Mar 27, 2014 7:37:04 GMT -5
GlaxoSmithKline's (GSK) new diabetes drug Eperzan was among four new pharma products recommended for approval at the end of last week by the European Medicines Agency (EMA). In its latest round of opinions, the Committee for Medicinal Products for Human Use (CHMP), which provides guidance on drugs for the EMA, also backed Bayer's hypertension treatment Adempas, Takeda's antipsychotic Latuda and Linepharma France's Hemoprostol for haemorrhage in women. Eperzan (albiglutide) stood out among the recommendations as it is GSK's entrance into the market for GLP-1 agonists – an area of diabetes treatment currently dominated by Novo Nordisk's Victoza (liraglutide). The CHMP recommendation covers the use of Eperzan to manage glycaemic control in people with type 2 diabetes as a monotherapy if metformin is inappropriate for the patient or as an add-on in combination with other diabetes treatments. It comes as a pre-filled pen injection and is taken once a week. The drug marks GSK's return to the massive diabetes market following severe restrictions in the US and suspension in the EU for its previous type 2 diabetes product Avandia (rosiglitazone) after it was linked to an increase in cardiovascular risk. The FDA restrictions were later lifted after further analyses. Forecasts for Eperzan are modest, however, as studies have shown it is not as effective as once-daily Victoza, while the US Food and Drug Administration (FDA) has announced it has delayed the expected review date of the drug by three months.
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Post by biotec on Mar 27, 2014 7:49:56 GMT -5
Thanks sav, Don't sound like anything to special,I know GSK got killed with Avandia.
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Post by StevieRay on Mar 27, 2014 8:56:07 GMT -5
www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002735/smops/Positive/human_smop_000634.jsp&mid=WC0b01ac058001d127On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Eperzan, 30 mg and 50 mg, powder and solvent for solution for injection in pre-filled pen intended for the treatment of type 2 diabetes mellitus. The applicant for this medicinal product is GlaxoSmithKline Trading Services Limited. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion. The active substance of Eperzan is albiglutide (ATC Code A10BX13) a glucagon-like peptide 1 (GLP-1) receptor agonist generated by fusion of a GLP-1 analogue to albumin, resulting in a much prolonged half life. Like native GLP-1, albiglutide leads to an enhancement of glucose-dependent insulin secretion and a reduction of glucagon release. The benefits with Eperzan are its clinically relevant effect on glycaemic control in patients with type 2 diabetes when used in combination with other glucose-lowering medicinal products including insulin or on its own when metformin cannot be used. Eperzan has a neutral effect on body weight. The most common side effects are nausea, diarrhoea and injection site reactions. A pharmacovigilance plan for Eperzan will be implemented as part of the marketing authorisation. The approved indication is: "Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as: - Monotherapy: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance. - Add-on combination therapy: In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations)". Detailed recommendations for the use of this product will be described in the summary 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 Eperzan and therefore recommends the granting of the marketing authorisation.
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Post by StevieRay on Mar 27, 2014 9:23:53 GMT -5
Looks like Eperzan will compete with our MKC253: GLP-1/Technosphere MKC253 is a formulation of GLP-1 (glucagon-like peptide) on Technosphere® particles that is delivered using our proprietary inhaler. In initial clinical studies, MKC253 has shown a robust enhancement of insulin secretion without gastrointestinal (GI) intolerance. Our hypothesis at present is that delivery of active GLP-1 to the arterial circulation, via the lung, avoids significant degradation by dipeptidyl peptidase-4 that occurs prior to the compound reaching the primary site of endocrine action. Thus, it may be possible to achieve a different response profile with pulmonary MCK253 than seen with subcutaneous or intravenous administration of GLP-1. Moreover, the pulsatile administration of MKC253 achieved with the Technosphere® delivery technology appears to avoid the dose-limiting GI intolerance characteristically associated with GLP-1 and replaces the insulin response lost in patients with diabetes that cannot be replicated by other forms of GLP-1. - See more at: www.mannkindcorp.com/product-pipeline-mkc253.htm#sthash.I4cbQjz2.dpuf
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Post by brentie on Mar 27, 2014 9:38:47 GMT -5
Looks like Eperzan will compete with our MKC253: GLP-1/Technosphere MKC253 is a formulation of GLP-1 (glucagon-like peptide) on Technosphere® particles that is delivered using our proprietary inhaler. In initial clinical studies, MKC253 has shown a robust enhancement of insulin secretion without gastrointestinal (GI) intolerance. Our hypothesis at present is that delivery of active GLP-1 to the arterial circulation, via the lung, avoids significant degradation by dipeptidyl peptidase-4 that occurs prior to the compound reaching the primary site of endocrine action. Thus, it may be possible to achieve a different response profile with pulmonary MCK253 than seen with subcutaneous or intravenous administration of GLP-1. Moreover, the pulsatile administration of MKC253 achieved with the Technosphere® delivery technology appears to avoid the dose-limiting GI intolerance characteristically associated with GLP-1 and replaces the insulin response lost in patients with diabetes that cannot be replicated by other forms of GLP-1. - See more at: www.mannkindcorp.com/product-pipeline-mkc253.htm#sthash.I4cbQjz2.dpufMannkind’s proposed solution to the problem is to administer regular human GLP-1 by inhalation, instead of by injection. Because inhalation gives direct access to the bloodstream, the GLP-1 will immediately enter the body, quickly signal the pancreas to release more insulin, and quickly be deactivated by DPP-IV. This should closely mimic the short burst of GLP-1 released by the healthy body and bring back the Phase 1 insulin spike of a healthy body. Indeed, in their first human trial, Mannkind found that their inhaled GLP-1, code-named MKC253, had the desired effect. MKC253 produced a sharp pulse of GLP-1 in the bloodstream that peaked in less than 3 minutes. This, in turn, induced a spike of insulin from the pancreas that peaked in less than 6 minutes. MKC253 is still in Phase 1 trials, so it still needs much further testing and is not close to market. However, being that this is simply administering a natural hormone found in the body but missing in diabetics, GLP-1, it is extremely likely to be found to be both effective and safe. In fact, since it is mimicking the natural function of a healthy body, it is likely to be safer than the first two methods outlined above, with fewer side effects. Byetta, although very effective, was found to have major side effects of nausea, vomiting, and diarrhea. As much as maybe 25% of patients can’t take Byetta for these reasons. Recently, the FDA added a warning to Byetta’s label that Byetta may cause acute pancreatitis (due to reports of acute pancreatitis in people taking Byetta). Presumably, these side effects come from the elevated levels of GLP-1 for an unnaturally long time and/or the differences between Byetta and GLP-1 (that make it resistant to DPP-IV breakdown). Mannkind’s inhaled GLP-1 would likely not have these problems because it is mimicking the natural body. Indeed, in their first human trial, Mannkind found that MKC253 was well tolerated by the trial participants. Even with the highest dosage of MKC253, they did not find any of the nausea and vomiting characteristically associated with such dosage levels. In fact, they reached levels of GLP-1 in the blood of more than 3 times the level which has been found to cause unacceptable side effects when injecting, and still found no side effects by inhalation! (By the way, it should be pointed out that all this talk about GLP-1 and DPP-IV is only pertinent to Type 2 Diabetics, whose bodies are still capable of making insulin. Type 2 Diabetics comprise 90% – 95% of all diabetics.) seekingalpha.com/article/81899-mannkind-overlooked-biotech-with-excellent-prospects-part-v
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