Smokeless tobacco devices that are marketed as a safer alternative to traditional cigarettes may not be as harmless as claimed, according to new research. IQOS – which stands for “I quit original smoking” – is a new “heat not burn” smokeless tobacco product manufactured by Philip Morris International (PMI), the biggest tobacco company in the world. PMI has conducted and published several extensive studies evaluating the effects of their new IQOS device. However, researchers from the University of California note that “these studies appeared in a journal that may have a deficient review process, emphasizing the need for independent evaluation of the iQOS.” Researchers conducted an independent review. Results indicated that people who use the iQOS heat stick tend to speed up their puff rate to breathe in more nicotine because the device only lasts for 6 minutes, after which it automatically shuts off and requires recharging. Published March 13, 2018. Via Tobacco Control.
Sarepta Therpeutics plans to submit an application for another Duchenne muscular dystrophy drug (DMD). In 2016, the FDA approved Sarepta’s currently marketed DMD drug, which went against the recommendation of a panel of independent advisors who said eteplirsen did not demonstrate clear efficacy in treating the rare muscle-wasting disease. Now, the company has submitted an application for the approval of golodirsen, which is a drug used to treat patients with DMD. This drug is said to help produce a smaller but functional form of dystrophin protein. A review conducted by Sarepta indicated that golodirsen significantly increased dystrophin protein production in 25 boys with confirmed deletions of the DMD gene amenable to exon 53 skipping. Published March 12, 2018. Via Sarepta.
The FDA is continuing to work with Abbvie and Biogen on the withdrawal of their multiple sclerosis drug from the market. Earlier this month, MedShadow reported that Zinbryta (daclizumab) would be voluntarily pulled from the market worldwide after reports of brain inflammation and severe liver damage. The FDA stepped in to assist with the process in order to “ensure a well-organized withdrawal from the market in the United States.” Furthermore, the agency wants to make sure that doctors are equipped with the necessary information to carefully transition their patients using Zinbryta to another treatment. Zinbryta will not be administered to new patients nor will new patients participate in clinical studies.The company has started notifying doctors and patients and Zinbryta will only be available for patients as needed until April 30, 2018. The FDA says that patients should not stop taking the medication without consulting their doctor. Published March 14, 2018. Via FDA.