Brenzavvy Receives FDA Approval
A new sodium-glucose co-transporter 2 (SGLT2) inhibitor, Brenzavvy™ (bexagliflozin – TheracosBio) tablets were approved by the U.S. Food and Drug Administration (FDA) on Jan. 20, 2023. It is taken as one 20mg tablet every morning to treat adults who have type 2 diabetes. Dietary changes and increased exercise should be used, as well. Brenzavvy can be taken alone or in combination with other drugs that treat diabetes. Patients who take any SGLT2 inhibitor should be aware of symptoms, such as general discomfort, nausea/vomiting, and shortness of breath, which could be a result of ketoacidosis. Ketoacidosis is a potentially life-threatening accumulation of acids and other chemicals in the blood when diabetes is not managed properly. Also, because drugs in the class decrease the kidneys’ ability to reabsorb glucose, kidney function should be checked before patients start treatment and periodically during therapy. Additionally, taking an SGLT2 drug may be associated with amputations of the lower leg, feet or toes. Patients using one of them should report infections or sores on their feet or legs to their doctors as soon as they are noticed. Other SGLT2 inhibitors marketed in the U.S. include Farxiga® (dapagliflozin) tablets, Invokana® (canagliflozin) tablets, and Jardiance® (empagliflozin) tablets plus several fixed-dose combinations of one SGLT2 with another oral antidiabetes medication. They are indicated to decrease the risk of cardiovascular (CV) disease or end-stage renal disease (ESRD) and decrease blood sugar, but Brenzavvy is not. Launch date and pricing plans for Brenzavvy are not yet available. Prescribing information for it may be found here.
Sezaby Launched to Treat Neonatal Seizures
Sun Pharma has released Sezaby™ (phenobarbital) injection in the U.S. An intravenous (IV) form of a barbiturate that has been used since the early 1900s, it is approved by the FDA to treat babies who have seizures during the first four weeks after birth. Typically, newborns who have seizures are in a neonatal intensive care unit (NICU). The first dose is given at 20mg/kg as a 15-minute infusion. If needed, a second dose may be administered at least 15 minutes later as 20mg/kg for full-term babies and 10mg/kg for those born prematurely. Maintenance therapy, which totals 4.5mg/kg daily split into two or three doses, begins eight to 12 hours after the first dose. Treatment should last for five days or less. Boxed warnings on Sezaby’s labeling remind prescribers that barbiturates may cause dependence and/or withdrawal when used with an opioid. Additionally, they caution that doses for patients who receive treatment for longer than the recommended duration should be reduced slowly to avoid serious withdrawal reactions. Unapproved use by adults or teenagers can result in abuse, addiction, misuse, and overdoses. The cost for Sezaby is not yet available. Generic phenobarbital injection, which is indicated for treating neonatal seizures, is the current standard of care. Other injectable therapies, including fosphenytoin and levetiracetam, are used second-line or later if seizures are not controlled. Look here for its full prescribing information.
Odactra Approved for Teens
Odactra® (house mite allergen extract) sublingual tablets have been FDA approved since March 2017, for treating patients between the ages of 18 years and 65 years who have nasal inflammation (allergic rhinitis) that may be accompanied by eye inflammation (conjunctivitis) from an allergy to dust mites. The age range was extended by the FDA on Jan. 24, 2023, to patients as young as 12 years old. Odactra is oral immunotherapy that contains small amounts of dust mite allergens. Once a dust mite allergy is verified by testing, patients allow one tablet to dissolve under the tongue each day. Full results may take up to 14 weeks to be achieved. The first dose should be given in a treatment facility where the patient can be monitored for one-half hour or longer for any signs of severe allergic reactions, which can include sudden drops in blood pressure and breathing difficulties. Boxed warnings also advise that Odactra should not be taken by patients who have severe asthma or other health conditions, such as unmanaged high blood pressure, or by those taking some drugs, such as beta-blockers. All patients who use it should be prescribed epinephrine rescue injectors, which they and their caregivers should be shown how to use in case of an allergic reaction. Prescribing information has been revised here.
Enjaymo Indication Extended
The indication for Enjaymo™ (sutinlimab-jome – Sanofi) was expanded by the FDA on Jan. 25, 2023. In February 2022, it became the only drug therapy specifically indicated to decrease red blood cell (RBC) transfusions for adults who have cold agglutinin disease. A rare type of autoimmune disorder, cold agglutinin disease, which affects fewer than 5,000 Americans, causes RBCs to disintegrate faster than normal. Patients develop anemia and other symptoms when they experience air temperatures that are lower than about 40˚F. By inhibiting complement 1 (C1), a type of immunoglobulin G antibodies that cause RBCs to form clusters, Enjaymo decreases the destruction of red blood cells. The indication now has been broadened to include all patients who have cold agglutinin disease whether or not they need RBC transfusions. Enjaymo is administered by IV infusions, usually over one hour, at a dose of 6,500mg (six vials) for patients who weigh between 39kg (about 86 pounds) and 75kg (165 pounds) or 7,500mg (seven vials) for those weighing more. The first two doses are given one week apart, then they change to once every two weeks. Here is the revised prescribing information.
New Indication for Keytruda
On Jan. 26, 2023, the FDA approved Keytruda® (pembrolizumab) injection, Merck’s programmed death receptor-1 (PD-1) inhibitor, for an additional subset of patients who have non-small cell lung cancer (NSCLC). The new indication is for use as an “adjuvant” treatment of adults after they have had surgery to remove and platinum-based chemotherapy (chemo) to treat certain stage IB, II, or IIIA NSCLC. In the clinical trial that prompted the approval, the average time before cancer returned was 58.7 months for patients who got Keytruda versus 34.9 months for patients receiving a placebo. Chances of death or cancer recurrence dropped by 27% with active treatment. The dose recommendation for all patients who have NSCLC is either 200mg once every three weeks or 400mg once every six weeks by IV infusion. Treatment lasts for two years until the cancer returns or until the patient is no longer able to endure therapy. Keytruda also is used alone or in combination with other cancer drugs to treat some kidney cancers; some esophageal, head and neck, lung, and stomach cancers; as well as Merkel cell carcinoma, multiple myeloma, and non-Hodgkin lymphoma. It also has indications for pediatric and adult patients whose cancers have specific genetic characteristics (biomarkers), rather than developing from a particular body tissue. Here is its updated prescribing information.
Emergency Use Authorization for Evusheld Revoked
The FDA retracted the emergency use authorization (EUA) for AstraZeneca’s Evusheld™ (tixagevimab co-packaged with cilgavimab) on Jan. 26, 2023. It presently is not authorized for use in the United States because it is not believed to be effective in preventing infection with COVID-19’s Omicron variants now thought to cause more than 90% of COVID-19 cases in the U.S. A combination of new long-acting monoclonal antibodies, Evusheld received the FDA’s EUA in December 2021, as the first drug indicated to prevent COVID-19. It was approved for immunocompromised patients who are 12 years old or older, who weigh 40kg (88 pounds) or more, and who had not been exposed to COVID-19. Patients who could not be fully vaccinated against COVID-19 due to a severe reaction to the vaccine also were candidates for use of Evusheld. The FDA advises that current supplies of Evusheld be stored rather than destroyed or returned, in the event that is reauthorized if future mutations of SARS-CoV-2, the virus responsible for COVID-19 may be susceptible to it. Evusheld’s updated Letter of Authorization and its Fact Sheet for Healthcare Providers have more information.