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[Sanofi and Regeneron] The FDA approved Dupixent^® (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. A regulatory filing for this age group is under review by the European Medicines Agency and submissions to regulatory authorities in additional countries are underway.

• The approval is based on data that includes a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg, based on body weight) plus low-potency topical corticosteroids (TCS) or TCS alone (placebo).
• Dupixent is a pre-filled syringe and is administered every four weeks based on weight as an injection under the skin.

CellCept® (mycophenolate mofetil) has received an expanded indication for use in recipients of allogenic heart, kidney, or liver transplants who are at least three months old. It is used in combination with other immunosuppressants to prevent organ rejection.

• The updated indication allows for CellCept’s use in pediatric recipients of allogenic heart and liver transplants. The drug, which first received FDA approval in 1995, was previously indicated for these uses in adults only.
• CellCept is available in oral form as tablets, capsules, and an oral suspension. It is also available as an intravenous (IV) infusion that can be used up to 14 days for patients unable to take one of the oral formulations, though patients should be switched to oral dosing as soon as possible. Recommended dosing is based factors that include the patient’s age and body surface area, the type of transplant received, and the dosage form being used.

Regeneron’s Dupixent® (dupilumab) is now indicated to treat patients at least six months of age who have moderate-to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable. It was previously approved to treat atopic dermatitis only in patients at least six years of age.

• First FDA approved in 2017, Dupixent is also indicated to treat asthma, eosinophilic esophagitis, and chronic rhinosinusitis with nasal polyposis.
• Recommended dosing for atopic dermatitis in children is based on the patient’s age and weight. Maintenance dosing can range from 200mg once every four weeks to 300mg once every two weeks. Dupixent is given by subcutaneous injection and can be administered at home.

The U.S. FDA has approved an expanded indication for Sanofi’s Lantus® (insulin glargine) to improve glycemic control in adult and pediatric patients who have diabetes mellitus (type 1 or type 2).

• Prior to this expansion, Lantus was indicated to improve glycemic control in adults who had type 1 or type 2 diabetes mellitus, and in pediatric patients who had type 1 diabetes mellitus.
• Lantus dosing is individualized based on the patient’s metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use.
• The FDA first approved Lantus in 2000.

Amgen’s Riabni™ (rituximab-arrx), a biosimilar for Rituxan® (rituximab – Genentech and Biogen), is now FDA approved to for use with methotrexate to treat moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

• The FDA first approved Riabni in 2020 to treat certain adults diagnosed with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s granulomatosis), and microscopic polyangiitis.
• Riabni’s recommended dosing for RA is two 1,000mg intravenous infusions separated by two weeks (one treatment course) every 24 weeks. If appropriate based on clinical evaluation, the time between treatment courses can be shortened to as little as 16 weeks.

GSK’s Priorix® (measles, mumps, and rubella vaccine, live) has gained FDA approval to provide active immunization for the prevention of measles, mumps, and rubella (MMR) in individuals who are at least 12 months old.

• Recommended dosing is one 0.5mL subcutaneous injection given at 12-15 months of age, followed by a second 0.5mL injection administered at 4-6 years of age.
  • If Priorix is not given on this schedule, the patient should receive the first and second doses at least four weeks apart.
  • Priorix can also be used to provide a second MMR vaccine dose for patients who have received a different MMR vaccine for their first dose.
• Priorix has launched at wholesale acquisition cost (WAC) of $87.31 per dose.

TG Therapeutics is removing Ukoniq® (umbralisib) from the U.S. market due to a potential increase in the risk of patient death.

• In 2021, the U.S. FDA granted accelerated approval for Ukoniq to treat marginal zone lymphoma and follicular lymphoma. Continued approval was contingent on the results of confirmatory trials.
• The FDA announced in February 2022 that it was investigating a possible increased risk of death in patients treated with Ukoniq. The agency advised healthcare professionals and patients to talk about the potential risks and benefits of the medication versus other available treatments.
• As of June 2022, the FDA concluded that the risks of treatment with Ukoniq outweigh the potential benefits. TG Therapeutics chose to voluntarily withdraw the drug from the market following this determination.

The U.S. FDA has approved Beovu® (brolucizumab-dbll) 6mg, made by Novartis, to treat diabetic macular edema (DME). DME is a leading cause of blindness in adults in developed countries.

• DME is the leading cause of new blindness in adults in the United States. It affects approximately 12% of individuals who have type 1 diabetes and 28% of those who have type 2 diabetes.
• This is Beovu’s second FDA-approved indication. The drug was first approved in 2019 to treat neovascular (wet) age-related macular degeneration.
• Recommended dosing under the new indication is 6mg once every six weeks for the first five doses, then 6mg once every 8-12 weeks for subsequent doses. Beovu is injected into the vitreous cavity at the back of the eye by a qualified healthcare professional.

• Caprelsa (vandetanib) – for cancer
• Viibryd (vilazodone hydrochloride) – for depression

Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting Program online, by mail, or by fax.

• Submit a Report Online:

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm

• Send a Report Via U.S. Mail or Fax:

Download a form from https://www.fda.gov/safety/reporting-serious-problems-fda/forms- reporting-fda or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the form or submit by fax to 1-800-FDA-0178.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.

Evrysdi® (risdiplam) has received expanded approval to treat spinal muscular atrophy (SMA) in patients of all ages. It was previously indicated for patients two months of age and older.

• SMA is a rare, progressive neuromuscular disorder that can affect a person’s ability to walk, eat, and breathe. Evrysdi, made by Genentech, first received FDA approval to treat SMA in 2020.
• Under the recommended dosing, Evrysdi should be given via oral syringe once daily after a meal. The dosage strength is based on the patient’s age and body weight:
  • Less than two months old:15mg/kg
  • Two months to less than two years old: 0.2mg/kg
  • At least two years old and weighing less than 20kg: 0.25mg/kg
  • At least two years old and weighing at least 20kg: 5mg