Tremfya Approved for Ulcerative Colitis
On Sept. 11, 2024, Tremfya® (guselkumab – Johnson & Johnson Innovative Medicine) injection was approved by the U.S. Food and Drug Administration (FDA) to treat adults with moderate-to-severe ulcerative colitis (UC). UC, which involves progressing chronic inflammation of the large intestines, is believed to affect more than one million Americans. Tremfya is an interleukin-23 (IL-23) inhibitor that blocks inflammatory processes. The subcutaneous (SC) version of Tremfya was originally approved in July 2017 to treat adults with moderate-to-severe psoriasis. It is also approved for active psoriatic arthritis. For treating UC, a newly-approved intravenous (IV) formulation is given by a health care professional at an induction dose of 200mg at weeks zero, four, and eight. The patient then transitions to the self-administered SC maintenance dose, either 100mg administered at week 16 and every eight weeks after or 200mg at week 12 and every four weeks thereafter. SC doses can be delivered through prefilled syringes or a self-injector. Because using Tremfya may increase the risk of having infections, patients should be tested for tuberculosis (TB) before beginning treatment. Tremfya is expected to receive another expanded approval for Crohn’s disease by April 20, 2025. Here is the updated prescribing information for Tremfya.
A New SC Dosage Form for Tecentriq
The FDA approved Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs – Genentech) on Sept. 12, 2024. This new SC formulation contains atezolizumab, a programmed death-ligand 1 (PD-L1) blocking antibody, for the treatment of various cancers combined with Halozyme’s Enhanze® drug technology, a proprietary recombinant human hyaluronidase enzyme, rHuPH20. This new formulation offers the first and only PD-L1 inhibitor to be injected subcutaneously. It is injected in seven minutes, while Tecentriq® (atezolizumab) must be administered as a standard IV infusion over 30-60 minutes. Studies showed comparable safety and efficacy profiles between IV and SC formulations and 71% of patients preferred the SC over the IV formulation due to less time in the clinic and increased comfort during treatment. Tecentriq Hybreza will be available for all indications of Tecentriq approved for adults in the U.S. Updated prescribing information is here.
Recall
Freestyle Libre 3 Sensors
On July 24, 2024, Abbott Diabetes Care, Inc. issued a medical device correction for FreeStyle Libre 3 Sensors because they can give an incorrectly high glucose reading, posing a potential health risk for people with diabetes. On Aug. 27, 2024, the FDA upgraded the device correction to a Class I recall. Affected patients should stop using the sensors immediately and request a replacement on the manufacturer’s website or contact the dispensing pharmacy. Since patients may not receive accurate readings from the sensor, there is a potential risk of calculating higher insulin doses than needed or delaying recognition of low blood glucose levels (hypoglycemia) that could lead to significant adverse health effects or death. To read more about the recall, see here.