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MannKind: Afrezza works just as effectively as competing diabetes drugs in trial

BY Alaric DeArment

VALENCIA, Calif. An investigational insulin made by MannKind works at least as well in patients with Type 1 diabetes as the standard therapy, MannKind said Thursday.

The drug maker said a 16-week clinical trial showed that the fast-acting inhaled mealtime insulin Afrezza (insulin human [rDNA origin]) combined with basal insulin worked as well as Eli Lilly’s injectable Humalog (insulin lispro [rDNA origin]). In addition, MannKind said, patients taking Afrezza showed lower rates of hypoglycemia – or low blood sugar – in after-meal and fasting blood glucose levels than those taking Humalog.

“Effectively controlling blood sugar levels and managing hypoglycemic events go hand in hand as key to successfully treating patients with Type 1 diabetes,” lead study investigator and University of Colorado medical professor Satish Garg said. “Our findings demonstrate that Afrezza may offer a significant advance from current mealtime insulin delivery methods, as it is comparable to the standard of care in glycemic control and provides the additional benefit of lower hypoglycemia rates.”

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Unigene appoints new CEO

BY Alaric DeArment

BOONTON, N.J. Unigene Labs has appointed a new leader, the company said Wednesday.

Unigene announced the appointment of Ashleigh Palmer as president and CEO, replacing Warren Levy. Unigene is the developer of Fortical (calcitonin salmon [rDNA origin]), a nasal spray for treating postmenopausal osteoporosis. The company has since licensed U.S. rights to Fortical to Upsher-Smith Labs.

“We are delighted to welcome Ashleigh to the Unigene team,” Unigene chairman Richard Levy said. “His areas of expertise and understanding of Big Pharma, as well as his appreciation for our oral delivery platform and peptide manufacturing capabilities, will help ensure Unigene maximizes its core assets and existing partnerships.”

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Bayer HealthCare: Betaferon’s safety record proven in follow-up trial

BY Alaric DeArment

BERLIN German drug maker Bayer HealthCare said a 16-year follow-up to a clinical trial of one of its multiple sclerosis drugs supported the drug’s safety record.

Bayer said results of the follow-up study for Betaferon (interferon-beta-1b), published Tuesday in the journal Neurology, revealed no new or unexpected harmful side effects emerging with long-term therapy, while observed side effects related to the drug decreased over time. The drug is marketed in the United States and Canada as Betaseron.

“These data confirm that Betaferon has a favorable safety and tolerability profile,” lead study author and University of Chicago neurology professor Anthony Reder said. “Over the years, healthcare professionals have been able to greatly reduce treatment-related adverse events and increase patients’ adherence to Betaferon therapy with dose escalation at initiation of therapy and the routine use of an autoinjector and co-medication with nonsteroidal anti-inflammatory drugs.”

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