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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 6 | Issue 10
May 15, 2024

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections

On April 24, 2024, the U.S. Food and Drug Administration (FDA) approved Pivya™ (pivmecillinam) tablets for the treatment of adult females with uncomplicated urinary tract infections (UTIs). Uncomplicated UTIs are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract and who were not recently catheterized. Approximately one-half of all women experience at least one UTI in their lifetime. Pivya™ works to treat UTIs involving the most common bacterial pathogens. Its efficacy in treating adult females with uncomplicated UTIs was assessed in three clinical trials. These trials measured the medication’s overall effect on symptom resolution and bacterial growth. Based on these measures, Privya™ was shown to have superior efficacy when compared to placebo or ibuprofen, and it had a similar response to an alternative oral antibacterial drug. The most common side effects of Pivya™ include nausea and diarrhea. It also has a warning for allergic reactions. Patients with a history of allergy to certain antibiotics should discuss this allergy with their health care provider to determine the risk of a similar response to Pivya™. The medication was granted Priority Review and Qualified Infectious Disease Product designations for the treatment of uncomplicated UTIs. 

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Drug Safety

Dr. Reddy’s Initiates Voluntary Nationwide Recall of Sapropterin Dihydrochloride 

On April 23, 2024, Dr. Reddy’s Laboratories, Inc. announced that it was voluntarily recalling five lots of Javygtor™ 100mg powder for oral solution and one lot of their generic version (Sapropterin Dihydrochloride Powder for Oral Solution 100 mg) due to decreased potency. The product is indicated to reduce phenylalanine (Phe) blood levels in patients with one type of phenylketonuria, a disorder in which a patient is unable to break down Phe. Less potent doses would be less effective in lowering Phe levels. When levels of Phe are chronically elevated, it can lead to seizures and permanent intellectual and developmental disability. Cartons of the recalled product contain 30 individual dosing packets. The affected lots of Javygtor™ include T2202812, T2204053, T2300975, T2300976 and T2304356 with expiration dates of 07/2025, 10/2025, 02/2026, 02/2026 and 08/2026, respectively. The affected lot of the generic product is T2200352 with an expiration date of 12/2024. The products were distributed nationwide to wholesalers/retailers. Patients with the affected lot should contact their physician prior to stopping the use of the product. Dr. Reddy’s is contacting distributors to arrange returns, and patients should return any recalled lots to their pharmacy. There have been no adverse events related to this recall to date, but patients should contact their health care provider if any problems arise from use of product. Adverse effects should also be reported to the FDA’s MedWatch Adverse Event Reporting program

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From the Pharmaceutical Industry

FTC Targets More Than 300 Potentially Improper Drug Patent Listings 

On April 30, 2024, The Federal Trade Commission (FTC) expanded its campaign against pharmaceutical manufacturers’ listing of patents in the FDA’s Orange Book that may be improper or inaccurate. The FTC is disputing "junk” patent listings for multiple blockbuster prescription medications used to treat diabetes, weight loss, asthma and COPD, including drugs such as Ozempic, Victoza and Saxenda.

As part of this expanded effort, the FTC notified the FDA of its concerns and sent warning letters to 10 companies, challenging the accuracy or relevance of more than 300 patent listings across 20 different brand name products. These patent listings are currently included in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations”, also known as the Orange Book. The Orange Book lists drug products approved by the FDA, along with related patent and exclusivity information for those products. Improper listing of patents in the Orange Book can delay cheaper generic alternatives from entering the market, keeping brand name drug prices high for a longer time. By challenging potentially improper patent fillings, the FTC is attempting to hasten the availability of generic alternatives to make these medicines more affordable for everyone.

The FTC initiated their campaign in September 2023 by releasing a policy statement regarding their scrutiny of medication patent listing in the Orange Book. In November, they challenged over 100 patent listings for medications specific to asthma and other inhaler devices, certain eye drops and epinephrine auto-injectors. In response to this warning, some manufacturers delisted patents from the Orange Book and others announced commitments to cap out-of-pocket costs for their products.

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FDA Approvals

New FDA Approvals

New Drug: Xolremdi(mavorixafor) 

Oral capsules indicated for the treatment of patients 12 years and older with WHIM (warts, hypogammaglobulinemia, infections, myelokathexis) syndrome, a rare genetic disease of the immune system in which white blood cells are trapped in the bone marrow. [4/26/24 - X4 PHARMACEUTICALS INC]

New Drug: OJEMDA® (tovorafenib)

Oral tablets and oral suspension indicated for patients 6 months or older with pediatric low-grade glioma (pLGG), a type of slow-growing brain tumor, that returned or did not respond to previous treatment and who have certain types of alterations of the BRAF gene. [4/23/24 - DAY ONE BIOPHARMACEUTICALS INC]

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New Generics

New Generics Entering the Marketplace

Myrbetriq® (mirabegron)

Indication: Treatment of overactive bladder (OAB) with symptoms of urinary urgency, frequency and leakage

Dosage Form/Strength: 25mg, 50mg oral extended-release tablets 

Average Wholesale Price (AWP): Generic = $497 | Brand = $552