A technology update, a new drug approval, and a drug recall due to more impurities.
Dexcom has announced an app update that allows its iOS users who have the G6 continuous glucose monitor (CGM) to ask Siri for glucose updates in real time. This first-of-its-kind innovation is considered a game-changer for people with diabetes—so much so that Apple’s newsroom featured it in its Siri shortcuts.
The app, first launched in 2018, connects to a wearable featuring a small sensor on the person’s lower abdomen that sends glucose data to a smart phone, smart watch or receiver.
“Based on feedback from our users, we are constantly evolving our technology to make living with diabetes more manageable,” Jake Leach, chief technology officer at Dexcom, said in a statement. “We listened and are excited to launch this app update to improve the overall user experience with G6 and add even more functionality to the world’s most powerful diabetes management tool.”
Soliqua 100/33, the combination therapy of insulin glargine and the glucagon-peptide-1 (GLP-1) receptor agonist lixisenatide previously approved for people with type 2 diabetes (T2D) whose diabetes is uncontrolled when using either of its components as a monotherapy, now has a new indication. FDA this week approved Soliqua for those with T2D whose diabetes is uncontrolled on oral antidiabetic medications.
The approval is based on clinical trial data that show that patients whose T2D was uncontrolled with metformin and a second oral medication had significantly greater reductions in blood glucose levels with Soliqua (74%) than with either insulin (59%) or lixisenatide (33%) alone.
In its statement, Sanofi said it would continue to offer its savings program for Soliqua that can limit or eliminate out-of-pocket costs for commercially insured patients regardless of formulary status.
FDA on Friday announced that AurbobindoPharma USA Inc would voluntarily recall another 38 lots of Valsartan USP and Amlodipine Valsartan USP tablets, which are indicated to treat high blood pressure and heart failure. The recall was due to the presence of an impurity known as N-Nitrosodiethylamine (NDEA). The announcement came a day after Hetero Labs Ltd. in India has announced a recall of 87 lots of losartan potassium tablets. The recalled losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
The voluntary recall to the consumer level was the latest in a series of recalls since July 2018 involving this class of drugs, called angiotensin II receptor blockers (ARBs) as impurities have been found both in the finished drugs and the active ingredients. The FDA’s update said that impurities may be result from the reuse of materials, such as solvents.
“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications, but it’s important to underscore that, based on the FDA’s initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure. That said, any presence of such impurities in drug products is not acceptable,” said FDA Commissioner Scott Gottlieb, MD.
He explained that FDA has determined the impurities “may be generated by specific chemical reactions in the manufacturing process of the drug’s active pharmaceutical ingredients." FDA scientists have developed new testing methods to detect and measure N-Nitrosodimethylamine (NDMA) and (NDEA) impurities in ARB medicines, and they are developing novel testing methods to detect additional nitrosamine impurities, including NMBA.
"We’re continuing to share these testing methods with international regulators, industry, and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity," Gottlieb said. "We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products. The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future.”
Recent FDA analyses in recalled valsartan found that the risk to individual patients is very low, although this doesn’t diminish FDA concerns, the agency statement said. “The FDA and drug manufacturers continue to test all ARBs for nitrosamine impurities. If NDEA, NDMA, NMBA, or other nitrosamine impurities are found in products at levels above the interim acceptable intake limits, the FDA will work with companies to swiftly remove affected products from the market,” according to the statement.