Musculoskeletal Disorders

The DISSOLVE I and II trials evaluated the efficacy and safety of 2 different dose levels of SEL-212 in adults 19 years of age and older with chronic refractory gout.

The approval of the new citrate-free, high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study.

Pulmonary function tests may be beneficial every six months, may be of use in initiating noninvasive ventilation when indicated

Some clinically meaningful improvements seen compared with education or inactive control

The table provided is a review of notable updates that occurred in February 2023 for investigational products in development.

February 2023 Notable Drug Approvals

No improvement seen in lower back pain with acetaminophen alone or placebo across trials

Latest findings are from a post hoc meta-analysis of pooled data from the DAPA-HF and DELIVER trials.

Kevzara approved for polymyalgia rheumatica; Skyclarys approved for Friedreich ataxia; Emergency authorization granted to at-home COVID-19, flu test; Drug-resistant bacteria virus spiking in the US; FDA clamps down on unlawful xylazine imports.

The approval was based on data from a phase 3 study which included adults with steroid-resistant active PMR who flared on at least 7.5mg per day of prednisone or equivalent during taper.

Plasma D-dimer had comparable accuracy to CRP, ESR, fibrinogen for diagnosing periprosthetic joint infection in patients with revision hip or knee arthroplasty

The Company is currently evaluating the efficacy and safety of taldefgrobep alfa in patients with SMA in the phase 3 RESILIENT study.

Belimumab is a B-lymphocyte stimulator-specific inhibitor.

A new dosing regimen for Turalio® (pexidartinib) is now available for the treatment of adults with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The recommended dose of Turalio is now 250mg orally twice daily (taken as two 125mg capsules) with a low-fat meal…

Amjevita is supplied as a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and as 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes.

High-dose therapy is not superior for most outcomes, except for the Knee Injury and Osteoarthritis Outcome Score for function in sports and recreation

No significant difference seen in incidence of death, deep vein thrombosis, pulmonary embolism, bleeding complications

AOC 1020 is designed to reduce the expression of DUX4 mRNA and DUX4 protein in muscles.

Investigators examined the risk of bone fracture associated with different forms of androgen deprivation therapy.

Long-term benefits seen in patients with inadequate response/intolerance to biologic or conventional disease-modifying antirheumatic drugs