FDA grants breakthrough therapy designation for novel type 1 diabetes pill was reported by Regina Schaffer for Healio.com/endocrinology, 14 April 2021. The FDA granted breakthrough therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes, according to a press release from vTv Therapeutics.
TTP399 is an investigational oral, once-daily glucokinase activator. Breakthrough therapy designation is based on FDA’s determination that preliminary clinical evidence indicates that an investigational therapy may demonstrate substantial improvement on one or more significant endpoints relative to available therapies for a serious or life-threatening condition. Once granted, breakthrough therapy designation provides a sponsor with added support and the potential to expedite development and review timelines for a promising new investigational medicine.
Steve Holcombe, CEO of vTv Therapeutics, said in the release. “Hypoglycemia remains a leading cause of morbidity and potential mortality in the treatment of type 1 diabetes. Patient and prescriber fear of hypoglycemia often precludes tight glycemic control, and this FDA designation highlights the potential of TTP399 to address this serious unmet medical need.”
Home-use HbA1c kits could aid virtual diabetes care was reported by Regina Schafer for Healio.com/endocrinology, 14 April 2021.
Capillary blood collection kits, suitable for home use, were shown to be easy to use and provided HbA1c measurements that are comparable to those obtained from venous specimens in the clinic, study data show. The findings were published in Diabetes Technology & Therapeutics.
“The take-home message is that with the two test kits used in the study, the accuracy of measuring HbA1c from a finger-stick blood sample is equal to that of a venous blood draw,” Roy W. Beck, MD, PhD, president and medical director of the Jaeb Center for Health Research Foundation Inc.
Way off-topic but interesting: The Latest Development in Toothpaste That’s a Definite “Must Know” was posted by Kathleen Hoffman for Medivisor.com, 28 March 2021.
Bioactive glass has been an additive in toothpaste in countries outside of the United State for around 10 years. But the FDA has only recently approved a bioactive glass toothpaste that can be obtained by prescription.
What’s so terrific about this type of toothpaste? After brushing with it, the bioactive glass reacts with saliva and forms a mineral layer that strengthens the enamel and protects against acids that can erode teeth. It also helps with sensitive teeth. Added benefits:
- Fluoride, calcium and phosphate combine to form a layer of fluorapatite on the surface of teeth. This protective layer can withstand acids of a pH of 4, protecting the teeth from stronger acids and remaining longer on the teeth.
- It is non-abrasive. Unlike whitening toothpastes which have large particles that can do a lot of damage to the surface of teeth, the particles in this toothpaste are small.