Another Stelara Biosimilar Approved, But Not Yet Launched
The U.S. Food and Drug Administration (FDA) approved Biocon Biologics’ Yesintek™ (ustekinumab-kfce), a Stelara® (ustekinumab – Johnson & Johnson Innovative Medicine) biosimilar, on Nov. 29, 2024. By inhibiting interleukins 12 and 23 (IL-12 and IL-23), ustekinumab interrupts processes involved in chronic inflammation. Yesintek, which will be available in subcutaneous (SC) and intravenous (IV) formulations, is approved for the treatment of Crohn’s disease (CD), ulcerative colitis (UC), plaque psoriasis and psoriatic arthritis (PsA). Yesintek will be marketed in the U.S. under a settlement agreement that allows its release for sale no later than Feb. 22, 2025. Several biosimilars to Stelara are expected to launch early next year, including FDA-approved Wezlana™ (ustekinumab-auub – Amgen), Selarsdi™ (ustekinumab-aekn – Alvotech/Teva), Pyzchiva™ (ustekinumab-ttwe – Sandoz), Otulfi™ (ustekinumab-aauz –Fresenius Kabi and Formycon) and Imuldosa™ (ustekinumab-srlf – Don-A ST/Accord). For complete prescribing information, please look here.
New Ready-to-Use Adrenaline Formulation Launched
On Dec 2. 2024, Endo announced the approval and launch of Adrenalin® (epinephrine in 0.9% sodium chloride injection) for the treatment of hypotension associated with septic shock. This is the first manufacturer-prepared ready-to-use premixed IV bag that does not require any preparation or compounding, and it holds a 24-month shelf-life at room temperature. Prescribing details may be found here.
Another Indication for Imfinzi
The FDA approved AstraZeneca’s Imfinzi® (durvalumab) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy on Dec. 4, 2024. It was reviewed using Assessment Aid and Project Orbis, which are FDA procedures that speed up approvals for drugs that may fill critical unmet needs. The phase III trial supporting approval, ADRIATIC, showed a statistically significant overall survival (OS) and progression-free survival (PFS) improvement when compared to placebo, and patients receiving durvalumab had the risk of death reduced by 27% and the risk of disease progression reduced by 24%. For the new indication, Imfinzi, a programmed death-ligand 1 (PD-L1) blocking immunotherapy, will be administered by IV infusion at a dosage of 1,500mg every four weeks for patients weighing 30kg or more and 20mg/kg every four weeks for patients weighing less than 30kg until disease progression, unacceptable toxicity, or a maximum of 24 months. Imfinzi has previous indications for treating adults who have types of non–small cell lung cancer (NSCLC), extensive-stage SCLC, or biliary tract cancer. Together, Imfinzi and Imjudo®(tremelimumab-actl) injections are approved to treat unresectable hepatocellular carcinoma (HCC) and NSCLC without EGFR, ALK or ROS1 mutations. They are used along with chemo which includes a platinum-containing drug. It is also used to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). For full prescribing details, click here.
MedWatch Update On Dec. 3, 2024, GSK announced that they had notified the FDA they had withdrawn all strengths of Jesduvroq® (daprodustat) tablets from the market for business reasons effective Dec. 19, 2024. Jesduvroq is used to treat anemia that is caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. According to the manufacturer, this voluntary action is not related to Jesduvroq’s safety or efficacy. Patients are advised to confer with their prescriber for alternative treatments. For more information, see here.