Auvelity Approved to Treat Depression

The U.S. Food and Drug Administration (FDA) approved Auvelity™ extended-release tablets on Aug. 18, 2022. Indicated to treat adults who have a major depressive disorder (MDD), it combines 45mg of dextromethorphan, which is an N-methyl D-aspartate (NMDA) receptor inhibitor, with 105mg of bupropion, which interferes with the activity of certain blood components. The result is higher blood levels of dextromethorphan and a longer duration of its effectiveness. In contrast to other current oral antidepressants, which may take several weeks to reach full effectiveness, Auvelity acts more quickly. In clinical studies comparing it to either placebo or bupropion, alone; it showed more positive effects at one week after the first dose and effectiveness lasted over the six-week long study periods. At least 5% of patients taking Auvelity in the trials had side effects that included diarrhea, dizziness, dry mouth, excessive sweating, headache, sexual dysfunction and sleepiness. A boxed warning cautions that children, teens and young adults who take antidepressants may consider or actually attempt suicide. For the first three days of treatment, patients take one tablet each morning. Then, the recommended maintenance dose increases to one tablet in the morning and one tablet at least eight hours later. Because it may raise blood pressure, patients should be checked before beginning to take Auvelity and regularly during its use. It should not be used for patients who have bipolar disorder or women who are pregnant. Auvelity was approved under the FDA’s Breakthrough Therapy and Priority pathways. Its launch is planned for the fourth quarter of 2022, but the price is not yet determined.

New Formulation for Hadlima

A citrate-free 100mg/mL formulation of Hadlima™ (adalimumab-bwwd), Samsung Bioepis/Organon’s biosimilar to Humira® (adalimumab – AbbVie), was FDA approved on Aug. 15, 2022. Hadlima’s 50mg/mL version was approved in July 2019. Under an agreement with AbbVie, both strengths will launch in July 2023, when several other biosimilars to the lower strength also will be marketed. Seven 50mg/mL Humira biosimilars are expected to be available in the U.S. before the end of 2023. A monoclonal antibody that inhibits tumor necrosis factor (TNF), adalimumab reduces inflammation. Its indications are for treating adults who have ankylosing spondylitis (AS), plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA) or ulcerative colitis (UC). Additionally, it is approved for treating children at least two years of age who have polyarticular juvenile idiopathic arthritis (JIA) and patients aged six years and older for Crohn’s disease. Generally, it is given by subcutaneous (SC) injections once every two weeks through prefilled syringes and auto-injectors. For many adult indications, the recommended maintenance doses are 40mg, after higher loading doses. Pediatric dosing is based on the child’s weight. A boxed warning on the labels of all TNF blockers and information in Medication Guides for patients outlines the increased risks of cancer and serious infections that may be associated with their use. Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Hadlima is not interchangeable with either strength of Humira or with other FDA-approved 50mg/mL biosimilars Abrilada™ (adalimumab-afzb – Pfizer), Amjevita™ (adalimumab-atto – Amgen), Cyltezo® (adalimumab-adbm – Boehringer Ingelheim), Hulio® (adalimumab-fkjp – Mylan/Fujifilm Kyowa Kirin Biologics), Hyrimoz™ (adalimumab-adaz – Sandoz) and Yusimry™ (adalimumab-aqvh – Coherus BioSciences).

Mirena Use Extended to Eight Years

The time that Bayer’s Mirena® (levonorgestrel-releasing intrauterine system) 52mg can remain in use as a long-term contraceptive was extended by the FDA on Aug. 12, 2022. Initially approved in 2000, the intrauterine device (IUD) has an additional indication for the correction of heavy menstrual bleeding for as long as five years for women who choose an intrauterine contraceptive. Its expanded approval means that it can be used continuously for contraception for as long as eight years before it must be removed. Of course, it can be removed at any time that the patient decides. In the clinical trial that supported longer use, Mirena stayed more than 99% effective from year six through year eight. Inserted and removed by a medical professional, it is not intended for emergency contraception, and it does not prevent sexually transmitted diseases (STDs). Women who are prone to pelvic or genital infections and those who have cancers that could be worsened by progestin should not use Mirena. Check here for its current prescribing information.

FDA Approves Bioequivalent for Cetrotide

The FDA approved Akorn Operating Company’s cetrorelix injection, 0.25mg, on Aug 15, 2022. The first bioequivalent for Cetrotide® (EMD Serono/Merck), it is administered – often by the patient — SC to block the release of luteinizing hormone (LH) that occurs too early during assisted reproductive technology (ART). Depending on the ART protocol, cetrorelix is given either as a single 3mg dose, or as 0.25mg doses on several consecutive days. Cetrotide’s 3mg dose remains prescription-only. Cost information and a release date are not yet available for Akorn’s bioequivalent cetrorelix product. Under the FDA’s Competitive Generic Therapy (CGT) program, Akorn will have 180-days of exclusivity beginning on the day it is launched. IQVIA estimates U.S. sales of Cetrotide at roughly $127 million for the calendar year 2022.

MedWatch Update

Glatiramer Auto-Injectors

In a safety communication released on Aug. 18, 2022, the FDA warned patients who use a glatiramer injection device that not all available devices can be used with all products. Branded Copaxone® and generics are self-administered SC – usually either one time a day or three times a week to treat multiple sclerosis (MS). Although they are packaged in pre-filled syringes, many patients use a separately prescribed auto-injector, which makes injections easier for those who have limited use of their hands. Because the devices are reusable, patients may try to use one that they already have, but that does not work with a change in the glatiramer product being injected. Doses could be incomplete. The FDA has asked manufacturers of the devices to add information that cautions patients about potential problems to their drug labels. It also is encouraging patients to check with their prescribers or pharmacists to be sure that the device they have will work with each new prescription. More information is in the FDA’s notice.