Approval for Xphozah
Xphozah® (tenapanor) tablets were U.S. Food and Drug Administration (FDA) approved on Oct. 17, 2023. Made by Ardelyx, it is the first phosphate absorption inhibitor. Indicated to lower the amounts of phosphorous in the blood, it will be add-on therapy for adults who need recurring dialysis to treat chronic kidney disease (CKD) but who cannot use or who do not respond sufficiently to currently available phosphate-reducing drugs. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD), about 550,000 individuals in the U.S. need dialysis on a regular basis to manage end-stage renal disease (ESRD). Increased phosphorous levels in the blood due to kidney damage can cause brittle bones, intense itching, joint pain, and muscle pain. Xphozah blocks sodium hydrogen exchanger 3 (NHE3) in the GI tract to restrict the absorption of phosphate in ways that are different from other available drugs. The recommended dose of Xphozah is 30mg twice a day – once before the first meal and once before the last meal of the day. Release to the U.S. market is planned for November 2023. The price has not yet been announced. Ardelyx also has another FDA approval for tenapanor, as the branded drug Isbrela®, to treat irritable bowel syndrome with constipation (IBS-C). For Xphozah’s full prescribing information, look here.
Zydus Lifesciences received FDA approval on Oct. 18, 2023, for Zituvio™ (sitagliptin) 25mg, 50mg, and 100mg tablets. The dipeptidyl peptidase-4 (DPP-4) inhibitor is indicated for use along with dietary modifications and increased exercise to treat adults who have type 2 diabetes. A freebase form of sitagliptin, Zituvio was approved as a new drug, not as a generic to Januvia® (sitagliptin – Merck) tablets, which uses a phosphate salt of sitagliptin. They are not interchangeable. Zituvio’s recommended dose is 100mg one time each day – either alone or in combination with metformin and/or pioglitazone. DPP-4 inhibitors should not be used to treat type 1 diabetes or for patients who have or have had pancreatitis. Zydus has not yet announced a launch date or its pricing plans. According to Merck’s 2022 annual report, sales of Januvia amounted to more than $2.8 billion for the year. Prescribing information is here for Zituvio.
Qlosi Approved to Treat Presbyopia
A new strength and preservative-free dosage form of the cholinergic receptor agonist, pilocarpine, was FDA-approved on Oct. 17, 2023. Qlosi™ Ophthalmic Solution, 0.4%, will be used to correct presbyopia (the inability to focus on close objects). Starting in their 40s, most individuals gradually develop presbyopia, which makes things that are near the eyes look fuzzy. When applied to the eye surface, pilocarpine causes the muscles in the eyes to contract, narrowing the pupil and enhancing near vision. With a recommended dose of one drop in each eye once a day, Qlosi began to work within about 20 minutes and close vision remained clear for up to eight hours among most patients in its clinical studies. If needed, a second drop can be used when clear vision fades. Patients should remove contact lenses before using Qlosi. Orasis Pharmaceuticals expects to launch it in the first half of 2024 at a cost that is not yet determined. Several other pilocarpine eye drops and ocular inserts available in the U.S. are indicated to treat glaucoma and ocular hypertension and to cause miosis (contraction of the pupil) – most often after eye examinations. In October 2021, Vuity® (pilocarpine ophthalmic solution, 1.25% – Allergan, an AbbVie Company) was FDA approved as the first, and currently only other, pilocarpine specifically indicated to treat presbyopia. Check here for its full prescribing information.
Opdivo Receives Expanded FDA Approval
Opdivo® (nivolumab) injection, an IV immune-oncology agent from Bristol Myers Squibb, was approved by the FDA for a new indication on Oct. 13, 2023. It now is approved to treat patients who are at least 12 years old and who had stage IIB or IIC melanoma that was completely removed by surgery. According to Bristol Myers Squibb, the American Joint Committee on Cancer estimates that melanoma returns within five years for about 35% of patients who have had stage IIB tumors removed and around 50% of patients whose removed melanomas were stage IIC. Opdivo’s recommended doses for the new indication are 240mg once every two weeks or 480mg once every four weeks for patients who weigh at least 40 kg (88 pounds) and 3mg/kg once every two weeks or 6mg/kg once every four weeks for those who weigh less than 40kg. In clinical trials, using Opdivo decreased the chance of melanoma recurrence, a new primary melanoma or death by 58% compared to placebo. After one year, only 11% of patients treated with Opdivo had a return of melanoma, versus 21% of patients using placebo infusions. A programmed death receptor-1 (PD-1)-blocking antibody, Opdivo has indications for several other cancers, including some other types and stages of melanoma, small cell lung cancer (SCLC), classic Hodgkin lymphoma and urothelial cancer. Along with Yervoy® (ipilimumab) injection, it is indicated for first-line treatment of adult patients who have esophageal squamous cell carcinoma (ESCC) that cannot be removed surgically and that has spread or worsened, specific kinds of renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC) and microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC). Additionally, Opdivo is approved for use along with chemotherapy (chemo) that includes fluoropyrimidine- and platinum-based drugs to treat ESCC. Its revised prescribing information is here.
Additional Indication for Keytruda
The indications for Merck’s PD-1 inhibitor, Keytruda® (pembrolizumab) injection also have been extended. On Oct. 16, 2023, the FDA approved it for treating resectable NSCLC before (neoadjuvant) and after (adjuvant) surgery. To qualify as resectable, the tumors must measure four or more centimeters or be node-positive. Neoadjuvantly, Keytruda is administered as a 30-minute IV infusion at 200mg once every three weeks or 400 mg once every six weeks for a maximum of 12 weeks along with chemo that includes a platinum-based drug. After tumors are removed, it will be administered by itself at the same dosages and intervals for up to 39 more weeks. Keytruda has five other FDA approvals with and without other cancer drugs for treating various other types and stages of NSCLC. It also is used alone or in combination with other cancer drugs to treat some kidney cancers; some esophageal, stomach, and head and neck cancers; as well as Merkel cell carcinoma, multiple myeloma, and non-Hodgkin lymphoma. It also has indications for pediatric and adult patients whose cancers have specific genetic characteristics (biomarkers), rather than developing from a particular body tissue. For its full prescribing information, look here.
New Pediatric Indication for Enbrel
On Oct. 18, 2023, Amgen’s Enbrel® (etanercept) injection was FDA-approved to treat children as young as two years old for juvenile psoriatic arthritis (JPsA). It is a tumor necrosis factor (TNF) blocker that is injected subcutaneously (SC) to reduce inflammation in the joints. For JPsA, the recommended dose is 0.8mg/kg up to a maximum of 50mg, once a week. Patients or caregivers can administer the shots. Enbrel has previous pediatric indications for treating children aged four years old and older for plaque psoriasis and those two years old and older who have polyarticular juvenile idiopathic arthritis (pJIA). Its indications for adults are ankylosing spondylitis (AS), plaque psoriasis, psoriatic arthritis (PsA), and rheumatoid arthritis (RA). Like all drugs that block the activity of TNF), Enbrel has boxed warnings outlining the increased chances that serious infections and some pediatric cancers may be associated with its use. Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Here is the updated prescribing information.