New add-on treatment for Parkinson’s disease “off” episodes receives FDA approval
On Aug. 27, 2019, the U.S. Food and Drug Administration (FDA) approved NourianzTM (istradefylline) tablets as an add-on treatment for “off” episodes associated with Parkinson’s disease (PD) in adult patients treated with levodopa/carbidopa. An “off” episode is a period of time when prescribed medication is not working effectively, which results in increased symptoms of PD such as tremor and difficulty walking. In four clinical trials involving 1,143 participants, NourianzTM demonstrated a significant decrease in “off” episode time compared to placebo over 12 weeks. According to the National Institutes of Health (NIH), PD is the second-most common neurodegenerative disorder in the U.S., with an estimated prevalence of about one million individuals.
FDA issues warning of rare but severe lung inflammation with certain breast cancer treatments
On Sept. 13, 2019, the FDA released a Drug Safety Communication informing the public of an increased risk of rare but severe lung inflammation associated with the use of cyclin-dependent kinase (CDK) 4/6 inhibitors, which is a class of medications commonly used to treat breast cancers. The safety warning is the result of an FDA review that evaluated cases of interstitial lung disease (ILD) and pneumonitis in patients using CDK 4/6 inhibitors in clinical trials and post-market safety databases. The FDA found that 1%-3% of patients analyzed had ILD/pneumonitis and of those patients, less than 1% had fatal outcomes. While within the Drug Safety Communication the FDA stated the benefits outweigh the risks when CDK 4/6 inhibitors are prescribed appropriately, manufacturers will still be required to update prescribing information and Patient Package Inserts for the entire class of drugs which includes Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib).
From the Industry
FDA advisory committee recommends approval for peanut allergy therapy
On September 13, 2019, the FDA Allergenic Products Advisory Committee (APAC) convened to deliberate the efficacy and safety of Palforzia® (AR101), a treatment developed to reduce the frequency and severity of allergic reactions to peanuts in patients diagnosed with a peanut allergy between the ages of 4 and 17 years old. The nine-member panel voted 7-2 in favor of Palforzia’s® efficacy data and 8-1 in favor of its safety profile, with a recommendation to require a REMS program to ensure safe prescribing and administration of the drug. If approved, Palforzia® will be the first standardized peanut allergen formulation to receive FDA approval. Current management for peanut allergy is limited to strict avoidance of peanuts and treatment with epinephrine for accidental exposure. The FDA is expected to provide a final approval decision in January 2020.
Recent FDA Approvals
Novel Dosage Form: GvokeTM (glucagon)
Injection for the treatment of severe low blood sugar in patients 2 years and older with diabetes [9/10/2019 – XERIS PHARMA INC]
New Combination: dolutegravir/lamivudine/tenofovir alafenamide fumarate
Oral tablets for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg [9/11/2019 – MYLAN LABS LTD]
Novel Drug Approval: Ibsrela® (tenapanor)
Oral tablets for the treatment irritable bowel syndrome (IBS) with constipation in adults [9/12/2019 – ARDELYX INC]
New Generics Entering the Marketplace
Amicar® (aminocaproic acid)
Indication: Severe bleeding
Dosage Form/Strength: 0.25GM/ML Solution
Average Wholesale Price (AWP): Generic =$808 | Brand = $851
Indication: Fungal infection
Dosage Form/Strength: 100MG Tablets
Average Wholesale Price (AWP): Generic = $6,661 | Brand = $7,401