New Xhance Indication

Xhance^® (fluticasone propionate) nasal spray was U.S. Food and Drug Administration (FDA) approved on March 15, 2024, to treat adults who have chronic rhinosinusitis even though they do not have nasal polyps. The inhaled corticosteroid originally was approved in 2017 for relieving congestion and inflammation caused by polyps in the nose. Xhance uses a proprietary delivery system developed by its manufacturer, Optinose^®. To use the nasal spray, the patient inserts part of the device into one nostril and then blows on another part to deliver 93mcg of fluticasone per spray. It is approved for both indications at a recommended dose of one spray into each nostril twice a day. Some patients may need to use two sprays per nostril twice a day and the full effects may not be reached for several weeks of regular use. Using Xhance may cause bleeding, fungal infections, irritation, or sores inside the nose. Check here for its complete prescribing information.

Expanded Indication for Iclusig

Takeda’s tyrosine kinase inhibitor (TKI), Iclusig^® (ponatinib) tablets gained Accelerated FDA Approval for an extended indication on March 19, 2024. Previously, it was indicated for treating adult patients who have chronic, accelerated, and blast phases of chronic myeloid leukemia (CML) that are resistant or refractory to prior tyrosine kinase inhibitor (TKI) therapy. It also is FDA approved to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that has returned or become nonresponsive to prior TKI therapy. Now, it can be used along with low-intensity chemotherapy (chemo) as a first-line treatment for Ph+ ALL. In the as-yet-uncompleted PhALLCON clinical trial, Iclusig plus chemo is being compared to imatinib plus chemo. Interim results show patients taking Iclusig are more likely to achieve complete remissions (CR) with minimal residual disease (MRD). As initial therapy, the recommended dose is 30mg once a day until an MDR-negative CR, and then 15mg once a day. Iclusig has a boxed warning that it may cause arterial blockages, blood clots, heart failure, and/or liver damage. Verification of the new approval, which was awarded under the FDA’s Priority and Real-Time Oncology Reviews, will be needed before full approval is granted. Here is the current prescribing information.

Age Range and Indication Extended for Spevigo

The FDA broadened its approval of Spevigo^® (spesolimab-sbzo – Boehringer Ingelheim) injection on March 18, 2024. Its initial approval in 2022 was limited to treating adults for flare-ups of generalized pustular psoriasis (GPP), which can be life-threatening. Now, it also can be given to treat patients who are at least 12 years old and who weigh 40kg (88 pounds), and it is indicated to prevent GPP episodes, as well. A rare form of psoriasis, GPP is believed to affect less than 0.05% of the general population. Although the two conditions are very different, about three-quarters of patients who have GPP also have plaque psoriasis. The major symptom of GPP is recurring episodes of extensive skin inflammation that causes pustules — small blisters that fill with pus. The pustules spread, forming larger lesions that split open and then form scabs. Other symptoms may include fatigue, fever, and elevated white blood cell counts. Flares can be spontaneous or associated with factors such as infectious diseases, some medications, pregnancy, or stress. Severe flares can result in heart failure, kidney failure, or sepsis. For preventing flare-ups, the recommended dose of Spevigo for patients who have not previously had an intravenous (IV) dose of it, is 600mg (four injections) given subcutaneously (SC) all at one time, followed by 300mg (two simultaneous SC injections) once every four weeks. To treat episodes of GPP, Spevigo is administered in a 90-minute IV infusion as a one-time dose of 900mg (two vials). If the flare has not resolved after one week, the dose may be repeated, one time. Treatment with Spevigo may increase the risk of infections. Its revised prescribing information is here.

Pediatric Indication and New Dosage Form for Edurant

Johnson and Johnson received FDA approval on March 15, 2024, for Edurant^® Ped (rilpivirine) tablets for oral suspension. A non-nucleoside reverse transcriptase inhibitor (NNRTI), it is used along with other antiretroviral drugs to treat HIV-1 for children who are at least two years old and who weigh between 14kg (31 pounds) and 25kg (55 pounds). The children must not have received prior treatment for HIV and their levels of HIV-1 RNA must be 100,000 copies/mL or less. For pediatric patients, doses are determined by weight, with five or six of the 2.5mg tablets dissolved in one teaspoonful (tsp) of water and taken right away along with one meal or snack per day. The dissolved tablets can be mixed into a tsp of applesauce, fruit juice, milk, or water if needed. Children who weigh more than 25kg should be transitioned to Edurant oral tablets which are not approved for patients weighing less than 25kg. Current prescribing information for both products may be found here.

AstraZeneca and GSK Lower Inhaler Prices

Following the lead of Bohringer Ingelheim, both AstraZeneca and GSK have announced that they will restrict the out-of-pocket (OOP) cost for all their inhaled drugs to $35 or less per month. AstraZeneca’s program, which begins on June 1, 2024, includes Airsupra^® (albuterol/budesonide), Breztri Aerosphere^® (budesonide/glycopyrrolate/formoterol fumarate), Symbicort^® (budesonide/formoterol fumarate) and others. GSK’s plan will cover products, such as Advair Diskus (fluticasone propionate/formoterol) Breo Ellipta (fluticasone furoate/vilanterol), and Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), for patients who currently pay more than $35/month for their inhaler. It will start on January 1, 2025. Both companies will release instructions on how to register for the cost reductions on their websites. Individuals who have drug coverage through Medicaid, Medicare or another federal government option are not eligible for the OOP limits. For more information, including complete lists of included drugs, check here for AstraZeneca and here for GSK.