FDA Gives First-Ever Approval For A Drug That Delays Type 1 Diabetes
The monoclonal antibody — manufactured by ProventionBio and Sanofi and will be marketed under the name Tzield — has been authorized by the FDA for use only in patients who have stage 2 type 1 diabetes, with an aim at delaying the onset of stage 3 of the disease.
CNN:
FDA Approves First Treatment To Delay Onset Of Type 1 Diabetes
A biologic therapy that delays the onset of type 1 diabetes received approval from the US Food and Drug Administration on Thursday. It is the first therapy approved for prevention of type 1 diabetes. The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield, from ProventionBio and Sanofi is given through intravenous infusion. (Christensen and Goodman, 11/17)
ABC News:
FDA Approves 1st Drug To Delay Onset Of Type 1 Diabetes
Tzield was approved to delay the onset of stage 3 type 1 diabetes in adults and children ages 8 and up who currently have stage 2 type 1 diabetes. The medication is thought to slow down the body's attack on its own insulin-producing cells and thus give people more time before they become dependent on pharmaceutical insulin. Tzield is not suitable for people with insulin-dependent type 1 diabetes, people who are pre-type 2 diabetics or those with type 2 diabetes. (Strauss and Winsor, 11/18)
Reuters:
U.S. FDA Greenlights Provention Bio's Diabetes Drug
"We expect to have drug in the channel by the end of the year," said Jason Hoitt, Provention's chief commercial officer, adding that preparations were underway with its partner Sanofi for a full launch in January 2023. (Satija, 11/17)
BBC:
Game-Changing Type 1 Diabetes Drug Approved In US
Experts say teplizumab marks a "new era" in treatment, tackling the root cause of the condition for the first time, rather than just the symptoms. ... It is likely to pave the way for approval decisions in other countries. (Mundasad, 11/17)
In other news about diabetes —
CIDRAP:
New-Onset Diabetes Risk Higher In Recovering COVID-19 Patients
People recovering from COVID-19 are at higher risk of a new diabetes diagnosis, a research team from Beijing reported this week in BMC Medicine. ... They note that an increased risk of diabetes has also been found for other viruses, but their analysis shows a 20% higher risk of developing diabetes following COVID compared to patients with other upper respiratory viruses and an 82% increased risk compared to the general population. (11/17)
The Japan Times:
Facing Stigma, People With Diabetes Seek Change Of Disease's Japanese Name
Nine out of 10 people with diabetes in Japan feel troubled by the disease’s Japanese name, saying it creates a stigma that the condition is filthy or caused only by bad habits, according to a recent survey of over 1,000 people who have the disease. Diabetes, called tōnyōbyō in Japanese, is written using the kanji characters for sugar (tō), urine (nyō) and disease (byō). But the image that conjures up doesn’t reflect the actual condition of the disease — which is characterized by high levels of glucose, a type of sugar, in the blood, not in the urine — according to the Japan Association for Diabetes Education and Care, the group of diabetes patients and medical professionals that conducted the survey. (Otake, 11/17)
