First oral treatment approved for moderately-to-severely active Crohn disease
The FDA approved AbbVie's once-daily Rinvoq (upadacitinib) for adults with moderately-to-severely active Crohn disease; it is the first oral treatment available for these Crohn disease activity index levels. Rinvoq is intended for use in adults who have had an inadequate response or have intolerance to one or more tumor necrosis factor blockers.
The efficacy and safety of Rinvoq were evaluated in two placebo-controlled induction trials of 857 patients with moderately-to-severely active Crohn disease. At week 12, a greater proportion of patients treated with 45-mg Rinvoq achieved clinical remission based on the Crohn's Disease Activity Index as compared with placebo in both trials. In addition, a greater proportion of patients treated with 45-mg Rinvoq demonstrated improvement in intestinal inflammation as assessed via colonoscopy.
Rinvoq is not recommended for use in combination with other Janus kinase inhibitors, biologic therapies for Crohn disease, or strong immunosuppressants.
FDA requires labeling updates for prescription stimulants to improve safe use
To address concerns of misuse, addiction, and overdose, the FDA is requiring updates to safety labeling and prescribing information for all amphetamine and methylphenidate products, stimulants used to treat attention-deficit hyperactivity disorder (ADHD) and other disorders. The updates are also intended to ensure that inconsistencies in prescribing information across the entire stimulants drug class are eliminated, as current labeling of some stimulants does not inform prescribers and users about the harms of misuse. With these changes, the FDA is taking aim at improper nonmedical use of this drug class, which is sometimes shared by patients with family and friends.
Healthcare providers are asked to assess patient risk of misuse and addiction before prescribing stimulants. Patients should be regularly assessed and monitored throughout treatment for signs and symptoms of nonmedical use, addiction, and potential diversion, which may be evidenced by more frequent renewal requests than warranted.
Patients should be counseled not to share their prescribed stimulants with anyone else. Adolescent patients and their parents should be educated on any prescribed medication's serious risks, proper storage, and proper disposal of any unused doses.
FDA approves once-daily heart failure treatment
The FDA approved Inpefa (sotagliflozin), a once-daily oral treatment to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent visits for HF, for use in adults with HF or with type 2 diabetes mellitus (T2DM), chronic kidney disease, and other cardiovascular risk factors. The approval was based in part on results from the SOLOIST-WHF study, which showed that Inpefa reduced the risk of total occurrence of hospitalization for HF, urgent visits for HF, and cardiovascular death by 33% in patients with T2DM recently hospitalized for worsening HF as compared with placebo.
Inpefa is a product of Lexicon Pharmaceuticals. It is expected to be available for these indications immediately.
New buprenorphine treatment option approved for opioid use disorder
The FDA approved Brixadi (buprenorphine) extended-release subcutaneous injections to treat moderate-to-severe opioid use disorder (OUD). Brixadi is available in two formulations: a weekly (50 mg/mL buprenorphine) or monthly (356 mg/mL buprenorphine) injection. The weekly formulation can be used in patients who have already started treatment for OUD with a single dose of a transmucosal buprenorphine product or those who are already being treated with buprenorphine. The monthly formulation can be used in patients already being treated for OUD with a buprenorphine product.
According to the FDA, patients receiving any medication for OUD cut their risk of death from all causes in half. Buprenorphine is a safe and effective option.
Brixadi is available through a risk evaluation and mitigation strategy (REMS) restricted distribution program and is administered only by healthcare providers in a healthcare setting. It is a product of Braeburn.