On Nov. 3, 2023, the U.S. Food and Drug Administration (FDA) approved Zituvimet™ tablets. It is a fixed-dose combination containing 50mg of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and 500mg or 1,000mg of metformin, a biguanide. Taken twice a day and used along with dietary modifications and increased exercise, it treats adults who have type 2 diabetes. Its manufacturer, Zydus Lifesciences, also received FDA approval in mid-October 2023, for Zituvio™ (sitagliptin) 25mg, 50mg, and 100mg tablets. Neither of the Zydus drugs is generic to or interchangeable with their brand counterparts, Merck’s Januvia® and Janumet®, because they use different salt forms of sitagliptin. DPP-4 inhibitors should not be used to treat type 1 diabetes or patients who have a history of pancreatitis. All drugs that contain metformin have a boxed warning that taking them may increase the risk of lactic acidosis, a rare, but potentially dangerous, accumulation of acids in the body. Zydus has not yet announced a launch date or its pricing plans for either Zituvio or Zituvimet. According to Merck’s 2022 annual report, sales of Janumet amounted to approximately $1.7 billion for the year. Look here to see Zituvimet’s prescribing information.
First Vaccine for Chikungunya Approved
Valneva Austria GmbH received the FDA’s Accelerated Approval on Nov 9, 2023, for Ixchiq® (chikungunya vaccine, live) injection. As the first vaccine to prevent infection with chikungunya virus (CHIKV), it is indicated for people who are at least 18 years old and who are at risk for infection either by living in or traveling to a place where the virus is common. Already widespread in tropical and subtropical areas of Africa, the Americas, and Asia, the prevalence of CHIKV is increasing in locations that are heating due to climate change. It has symptoms, such as fever, headaches, and muscle pain that are similar to those of some other viral illnesses. Possibly severe joint pain that it also often causes may last for extended periods. No specific treatment presently is available for CHIKV. To prevent it, Ixchiq is given as a single intramuscular (IM) injection. Because it includes a live form of the virus, it may cause temporary symptoms similar to those of CHIKV infection. Valneva expects to launch Ixchiq after the Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) reviews it in February. The FDA approved it under its Breakthrough Therapy, Fast-Track, and Priority review designations. It also earned a Tropical Disease Priority Review Voucher, which facilitates FDA review of a future drug application. Valneva plans to finance further research by selling the voucher to another company. Positive results from continuing clinical trials will be needed before full approval is granted. Complete prescribing information is here.
New Indications for Exparel
The indications for Exparel® (bupivacaine liposome injectable suspension – Pacira BioSciences) were extended by the FDA on Nov. 10, 2023. They now include its use as an adductor canal block or a sciatic nerve block in the popliteal fossa for adults undergoing surgical procedures, such as bunionectomies, that involve the lower legs, feet, and ankles. It also has previous FDA approval to produce postsurgical regional analgesia for adults when given through an interscalene brachial plexus block. The brachial plexus includes the nerves in the shoulders; scalenes are muscle groups at the sides of the neck. Temporarily numbing the area stops nerve signals to the spine and lessens pain after an upper-arm surgery, such as a rotator cuff repair. The recommended dose for regional effects in adults is 133mg (10mL). It is given before the surgery into the tissue near the nerves that serve the affected area. On the U.S. market since 2011, Exparel also is approved to provide localized pain relief for patients who are at least six years old. With an upper limit of 266mg, it is administered as an infiltration (saturation of a small area through several small injections) for localized effects. Due to its unique formulation, it releases bupivacaine slowly, relieving pain for 96 hours or longer. Exparel is not interchangeable with other injected local anesthetics, which must be used in larger volumes or given through a catheter. It can be used along with other pain relievers, including opioids. However, patients who receive it typically need fewer other pain medications for shorter amounts of time. Here is its revised prescribing information.
On Oct. 31, 2023, the Harvard Drug Group recalled to the consumer level all lots of two over-the-counter (OTC) eye drops labeled as Rugby brand. An FDA inspection found unsanitary conditions, including bacterial contamination, at the manufacturing facility. Using the potentially adulterated drops could cause eye infections that could result in partial or complete vision loss. The FDA notice about the recall is here. Several other OTC eye drops that were included in an FDA safety notice have not been recalled.