Generic to Motegrity Approved and Launched

On Jan. 2, 2025, Ani Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved prucalopride tablets, the first generic for Motegrity^® (prucalopride – Takeda). Originally approved in 2018, it was the first selective serotonin-4 (5-HT4) receptor agonist approved to treat adults who have chronic idiopathic constipation (CIC). Ani announced the tablets are available and have a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity. According to IQVIA, annual sales of prucalopride tablets in the US are around $167 million. A link to the prescribing information for brand Motegrity is found here.

New Subcutaneous Opdivo Qvantig Formulation Approved

The FDA approved Bristol Myers Squibb’s Opdivo Qvantig™ (nivolumab hyaluronidase-nvhy) on Dec. 27, 2024. This is the first subcutaneous (SC) formulation of Opdivo^®, a programmed death receptor (PD-1) blocking antibody approved across all adult solid tumor indications for Opdivo^®, either alone as maintenance therapy, maintenance therapy following completion of Opdivo plus Yervoy^® (ipilimumab – Bristol Myers Squibb) or in combination with chemotherapy or cabozantinib. Opdivo Qvantig utilizes hyaluronidase, an enzyme that assists in SC drug absorption that decreases the treatment time from a 30-minute intravenous (IV) infusion to a three-to-five-minute SC injection. For full prescribing information, please click here.

Gastric and Gastroesophageal Cancer Indication for Tevimbra

BeiGene announced the FDA approval of a new Tevimbra^® (tislelizumab-jsgr) indication on Dec. 27, 2024. Originally approved earlier in 2024 for inoperable or metastatic esophageal squamous cell carcinoma (ESCC), Tevimbra is now approved in combination with chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express programmed cell death protein 1 (PD-1). The phase III trial demonstrated a statistically significant and clinically meaningful improvement in overall survival of 15 months compared to 12.9 months for those treated with placebo plus chemotherapy. The recommended dose is 200mg given as an IV infusion once every 21 days for the immunoglobulin G4 (IgG4) PD-1 inhibitor. Prescribing information can be found here.

MedWatch Update

Trikafta Boxed Warning

On Dec. 20, 2024, a previous warning about drug induced liver injury and liver failure was upgraded to a boxed warning for Vertex Pharmaceuticals’ Trikafta^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor). Trikafta is indicated for treatment of cystic fibrosis (CF) in patients aged two years and older who have at least one F508del mutation in the CFTR gene or mutation in the CFTR gene that is responsive based on clinical and/or in vitro data. For prescribing information, see here.

Recalls

Recalls for Prograf and Astagraf XL

On December 24, 2024, Astellas Pharma US, Inc. issued a recall for one lot of Prograf^® 0.5 mg (tacrolimus) and one lot of Astagraf XL^® 0.5 mg (tacrolimus extended-release) capsules at the consumer level. This recall is being conducted because the affected lots may contain empty capsules. Prograf and Astagraf XL are immunosuppressants used in combination with other medications to prevent the rejection of certain organ transplants. Taking empty capsules from these recalled products could increase the risk of organ, tissue, or cell rejection in patients. For more information, see here.

Progesterone injection recalled

On Dec. 30, 2024, Eugia US LLC has initiated a voluntary recall for one lot of progesterone injection USP, 500mg/10mL vials. This recall is due to a product complaint regarding a piece of glass found in the vial. The presence of foreign particles like glass can induce an inflammatory response, which may result in pain, swelling, redness, and heat at the injection site. Progesterone injection is a hormone that is commonly prescribed for several uses, including hormone replacement therapy, menstrual disorders, assisted reproductive technology (ART), endometrial hyperplasia prophylaxis, abnormal uterine bleeding due to hormonal imbalance and other off label indications. For more information about the recall, see here.