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FDA approves an expanded indication for BYETTA injection

October 31, 2009

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is after this approved for use for example a stand-alone medication (monotherapy) along with diet and pursue to become better glycemic manage in adults with type 2 diabetes. Previously, it was approved for employment only in patients who were also distress other customary diabetes medications and had not achieved adequate glycemic command.

"The expanded indication gives physicians the election to prescribe BYETTA taken in the character of a first-line method of treating, increasing the number of patients who may favor from the medication and providing an opportunity to enjoyment patients with BYETTA earlier in the disease," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "Type 2 diabetes is a complex disease, in this way it is essential that healthcare professionals and their patients have a wide collocation of treatments that can effectively restrain blood starch-sugar levels."

The approval of BYETTA as a monotherapy treatment was based on a clinical ponder of patients by type 2 diabetes who were unable to execute glycemic control through diet and exercise alone. Study findings showed that patients treated with 5 mcg or 10 mcg of BYETTA as monotherapy reduced their A1C, a indefinite quantity of average blood sweeten too three months, by dint of. 0.7 percentage points and 0.9 percentage points, respectively, and lost 6.0 pounds and 6.4 pounds, respectively. Results of this study were published in Clinical Therapeutics in August 2008.

Among treatment-emergent adverse events, nausea was reported by the greatest incidence (5 mcg, 3 percent; 10 mcg, 13 percent). Hypoglycemia was reported in 5 percent of patients taking 5 mcg and 4 percent of patients taking 10 mcg, with no severe hypoglycemic events.

In addition to the monotherapy indication, the FDA approved changes to the BYETTA Prescribing Information to incorporate updated safety information, including pancreatitis-related language added to the Warnings and Precautions segment. This update addresses the alert issued by the FDA in August 2008. The reinvigorated label also expands upon existing language regarding application of BYETTA in patients by renal impairment. In adding, the label has been amended to proportion the format the FDA currently uses for Prescribing Information. This label update is existence communicated to physicians via a "Dear Healthcare Professional" letter, which will be available at www.BYETTA.com.

"Patient safety is our foremost concern at Amylin and Lilly, and the BYETTA Prescribing Information represents one important distance to communicate the information that healthcare professionals and patients destitution in rank to use the medication safely and effectively," Kolterman continued. "Thus, the updated label offers the greatest number general intelligence about the benefit-risk profile of BYETTA as a foundational therapeutic choice for people by type 2 diabetes."

BYETTA has been used by else than one million patients seeing that market introduction in 2005. It has a proven chronicle with more than 10 a thousand thousand prescriptions written and 6.5 years of clinical experience.

SOURCE Amylin Pharmaceuticals, Inc.

Written by Samanta · Filed Under Actoplus 

Roche discloses the results of first Phase III clinical study using Taspoglutide

October 28, 2009

Ipsen (Paris:IPN), an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed the results of a first phase III clinical study using Taspoglutide, the first human formerly weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s Research. Results from Roche’s Phase III scrutinize T-EMERGE 2 met its primary endpoint of make different in HbA1c (subcutaneous weekly taspoglutide versus subcutaneous twice-daily exenatide, as add-on to metformin, a thiazolidinedione [TZD], or metformin and a TZD). A superiority versus exenatide was demonstrated.

This hotch-potch is similar to the natural hormone GLP-1 that has a key role in blood flatter regulation. GLP-1 analogues, which inflame insulin secretion and hush up glucagon secretion, are constant innovations in the diabetes field.

The results showed that taspoglutide demonstrated greater HbA1c reduction versus exenatide following 24 weeks of treatment. The study analysis included 1,189 patients, equally randomized into three active deeds of arms (taspoglutide 10 mg once weekly, taspoglutide 10 mg once weekly titrated up to 20 mg formerly weekly after 4 weeks, and exenatide 10 mcg two times quotidian). Taspoglutide was generally well tolerated. The in the greatest degree often reported conflicting events amid taspoglutide and exenatide treated patients were nausea and vomiting.

http://www.ipsen.com/

Written by Samanta · Filed Under Actoplus 

Santarus to present results from two investigator-initiated studies with ZEGERID at 2009 ACG meeting

October 24, 2009

Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical party, today announced that positive data from two investigator-initiated studies through ZEGERID® (omeprazole/sodium bicarbonate) have being inclined exist presented in poster sessions at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting seizure courtyard in San Diego. These studies were supported by grants from Santarus.

Poster P424: Randomized Open-Label Trial to Assess the Impact of Dosage Timing of Omeprazole/Sodium Bicarbonate (Zegerid 40 mg) on Healing of Severe Reflux Esophagitis: Preliminary Results
(D Francis, MD, et al) - Monday, October 26, 2009, 10:30 a.m. – 4:00 p.fray. Pacific Time

This poster discusses preliminary results from a prospective open-label con over with ZEGERID 40 mg administered in spite of 8 weeks, either in the morning previous to breakfast or at bedtime, in treating subjects with severe erosive esophagitis (LA Grade C and D). For optimal efficacy, proton pump inhibitors (PPIs) are taken on an empty stomach 20 to 60 minutes previous to a meal, which can be cumbersome. The purpose of the study is to determine on the supposition that ZEGERID taken at bedtime offers an choice option for the treatment of severe erosive esophagitis. The end is to banquet 100 subjects>

Poster P833: Retrospective Assessment of Immediate-Release Omeprazole/Sodium Bicarbonate in Improvement of GERD Symptoms in Patients Who Failed Delayed-Release Proton Pump Inhibitors
(J Jolley, MD) - Tuesday, October 27, 2009, 10:30 a.m. – 4:00 p.m. Pacific Time

This open-label retroactive review of medicinal records from 50 patients who failed one or more delayed-release proton pump inhibitors (PPIs) evaluated the effectiveness of ZEGERID 40 mg in controlling symptoms of gastroesophageal ebb. disease (GERD).

Source: Santarus, Inc.

Written by Samanta · Filed Under Actoplus 

Liraglutide drug causes less nausea and hypoglycaemia compared to exenatide

October 21, 2009

New given conditions steady patient treatment satisfaction from the LEAD(TM) 6 experimental knowledge presented adhering the 22nd October at the 20th World Diabetes Congress (International Diabetes Federation) shows that patients have higher overall treatment satisfaction with liraglutide than they do through exenatide.(1)

To view the Multimedia News Release, please click: http://multivu.prnewswire.com/mnr/prne/novo/37559/

Specifically, among the 379 patients who completed the Diabetes Treatment Satisfaction Questionnaires (DTSQ) during the LEAD(TM) 6 sorrow, those taking liraglutide perceived less hypoglycaemia (abnormally low blood sugar levels) or hyperglycaemia (abnormally high courage compliment levels) compared to those on exenatide.

"Liraglutide has shown here in a convincing study that it is associated with less nausea, smaller perceived hypoglycaemia and definitely higher calm comfort compared to exenatide," said Dr Wolfgang Schmidt, professor and chair of the Department of Medicine at St. Josef-Hospital and one of the principal investigators in the experiment.

"Patient-reported outcomes data is an important extension of the efficacy data. If a long-suffering is satisfied by his or her treatment, then they are much more well-adapted to really stick to the management over the long term, which is that cannot be spared in model 2 diabetes," Dr Schmidt noted.

Treatment satisfaction was also evaluated during an open-label dilation of the LEAD(TM) 6 trial, in what one. patients were either switched from exenatide to liraglutide or continued onward liraglutide for not the same 14 weeks. These results show that switching patients from exenatide to liraglutide further improves enduring satisfaction, as evidenced by the larger rise in DTSQs scores for switched patients compared to those who continued upon the body liraglutide from weeks 26-40.

Other lock opener liraglutide data at IDF Congress

Two withdrawn meta-analyses of all six LEAD(TM) (Liraglutide Effect and Action in Diabetes) trials were likewise presented at the meeting. Meta-analyses are a type of statistical analysis that summarise the results on the side of a given method of treating from several different studies in order to evaluate its overall effect on a characteristic outcome.

The meta-analyses presented at the meeting documented:

1) Liraglutide’session substantial effect on lipid profile in patients with form 2 diabetes(2) and 2) liraglutide’s ability to subside one as well during the time that the other HbA1C and weight without inducing hypoglycaemia versus that of the other active comparators in the LEAD(TM) programme including exenatide, glimepiride, rosiglitazone and insulin glargine.(3) Each of the meta-analyses comprised 3,967 people with impressed sign 2 diabetes.

In the lipid meta-analysis, sum cholesterol, unhandsome density lipoprotein, free fatty acids and triglycerides were quite statistically significantly reduced from baseline with liraglutide extremely 26 weeks of treatment. Furthermore, gross cholesterol and low density lipoproteins were significantly reduced through liraglutide manipulation compared to rosiglitazone, glimepiride or insulin glargine.

In the meta-analysis evaluating effectiveness on combined treatment targets of HbA1c and consequence without hypoglycaemia, greater quantity patients in the liraglutide group reached HbA1c(less than)7.0% with no weight gain or hypoglycaemia than those on comparator treatments. Patients were more likely to reach these treatment goals without hypoglycaemia on liraglutide compared to other commonly used diabetes treatments.

LEAD(TM) 6 trial, extension and sub-analysis designs

LEAD(TM) 6 was a 26-week, open-label trial of 464 patients with type 2 diabetes and HbA1c levels between 7-11%, who were randomised to once-daily liraglutide or twice-daily exenatide on a metformin more or minus sulphonylurea therapy background. Results from this direct comparison trial were published in The Lancet.

In the LEAD(TM) 6 extension testing, patients were one and the other switched from exenatide to liraglutide or continued on liraglutide for a period of 14 weeks. All 389 patients who completed the randomised trial entered into the extendedness phase.

In the patient-reported outcomes analysis, a subgroup of 379 patients had treatment satisfaction evaluated using sum of two units versions of the Diabetes Treatment Satisfaction Questionnaire: status (DTSQs) at baseline and week 26, and change (DTSQc) at week 26. Patients had higher overall treatment satisfaction with liraglutide than they did with exenatide and, in particular, their perception of hyperglycaemia and hypoglycaemia was reduced more by dint of. liraglutide than by exenatide.

In the 14-week extendedness, 313 patients answered the DTSQs at weeks 34 and 40 and the DTSQc at week 34. These results showed that switching patients from exenatide to liraglutide further improves patient satisfaction, as evidenced by the larger go in treatment reparation scores towards switched patients compared to those who continued in succession liraglutide from weeks 26-40.

Source: NOVO NORDISK

Written by Samanta · Filed Under Actoplus