Updates from FDA
New drugs
ANIFROLUMAB-FNIA
(Saphnelo—AstraZeneca)
Drug class: Type I interferon receptor antagonist.
Indication: For treatment of adult patients with moderate to severe systemic lupus erythematosus, who are receiving standard therapy.
Recommended dosage and administration: Intravenous infusion of 300 mg in a single-dose vial over a 30-minute period every 4 weeks.
Contraindications: History of anaphylaxis with anifrolumab-fnia.
Common adverse events: Nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster, and cough (incidence ≥5%).
Warnings and precautions: Monitor patients for serious and sometimes fatal infections; hypersensitivity reactions including anaphylaxis; and malignancy. Avoid use of live or live-attenuated vaccines in patients receiving Saphnelo. Saphnelo is not recommended for use with other biologic therapies.
TRETINOIN/BENZOYL PEROXIDE
(Twyneo—Sol-Gel Technologies Ltd.)
Drug class: Combination of 0.1% tretinoin and 3% benzoyl peroxide.
Indication: Topical cream treatment for adult and pediatric patients aged 9 years and older with acne vulgaris.
Recommended dosage and administration: Apply a thin layer of Twyneo to the affected areas once daily. Avoid contact with eyes, lips, paranasal creases, and mucous membranes, and wash hands after application.
Contraindications: History of serious hypersensitivity to benzoyl peroxide.
Common adverse events: Application site pain, dryness, exfoliation, erythema, dermatitis, pruritus, and irritation.
Warnings and precautions: Monitor patients for hypersensitivity reactions, including anaphylaxis and angioedema; skin irritation; and photosensitivity. Minimize unprotected exposure to sunlight and sunlamps. Avoid application of tretinoin/benzoyl peroxide to cuts, abrasions, or eczematous or sunburned skin.
BELUMOSUDIL MESYLATE
(Rezurock—Kadmon Pharms LLC)
Drug class: Kinase inhibitor.
Indication: For treatment of adult and pediatric patients aged 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy.
Recommended dosage and administration: 200 mg tablet taken orally once daily with food.
Drug interactions: Increase dosage to 200 mg twice daily when using strong CYP3A inducers or PPIs.
Common adverse events: Infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, decreased phosphate, increased gamma glutamyl transferase, decreased lymphocytes, and hypertension.
Warnings and precautions: Advise females of reproductive potential of embryo-fetal toxicity risk and to use effective contraception. Also advise against breastfeeding.
FEXINIDAZOLE
(Fexinidazole—DNDI)
Drug class: Nitroimidazole antimicrobial.
Indication: For treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients aged 6 years and older and weighing at least 20 kg. Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count >100 cells/µL) due to T. brucei gambiense disease, fexinidazole tablets should only be used in these patients if there are no other available treatment options.
Recommended dosage and administration: Administer once daily with food at about the same time of the day. Do not break or crush tablets. See full prescribing information for dosing recommendations of the 600 mg tablets.
Contraindications: Known hypersensitivity to fexinidazole, and/or nitroimidazole drugs and in patients with hepatic impairment.
Drug interactions: Avoid use of herbal medicines and supplements and see full prescribing information for complete list of clinically significant drug interactions.
Common adverse events: Headache, vomiting, insomnia, nausea, asthenia, tremor, decreased appetite, dizziness, hypocalcemia, dyspepsia, back pain, upper abdominal pain, and hyperkalemia.
Warnings and precautions: Monitor patients for decreased efficacy in severe HAT. Avoid use in patients with known QT interval prolongation, proarrhythmic conditions, and concomitant use with drugs that prolong the QT interval, those that block cardiac potassium channels, and/or those that induce bradycardia, or are inducers of hepatic CYP450.
Monitor patients for neuropsychiatric adverse effects such as agitation, anxiety, abnormal behavior, depression, suicidal ideation, nightmares, hallucination, and personality change.
Avoid use in patients who have taken disulfiram within the last two weeks. Avoid concomitant use of drugs that may cause neutropenia and monitor leukocyte count periodically. Where there is the potential for hepatotoxicity, evaluate liver-related laboratory tests at the start and during treatment.
Advise patients to avoid consumption of alcohol during treatment with and for at least 48 hours after completing therapy to avoid risk of a disulfiram-like reaction.
Breast cancer treatment approved by FDA
FDA has approved pembrolizumab (Keytruda—Merck) for treating triple-negative breast cancer (TNBC) in combination with chemotherapy. FDA’s decision marks the first time a treatment involving an immunotherapy was approved for patients with early-stage TNBC, which has a higher recurrence rate. Pembrolizumab is designed to help the immune system find and attack tumor cells and is currently approved to treat 30 types of cancer in the United States. FDA’s approval followed a trial involving more than 1,100 patients with early-stage TNBC, in which pembrolizumab was used with chemotherapy prior to surgery and as a monotherapy post-surgery. The trial results demonstrate that the treatment could help lengthen the amount of time a patient remains free of certain cancer-related events, such as recurrence.
“Today’s approval is very welcome news and has the potential to change the treatment paradigm by now including an immunotherapy as part of the regimen for patients with high-risk early-stage TNBC,” said Joyce O’Shaughnessy, chair of breast cancer research at Baylor University Medical Center.
FDA approves first interchangeable biosimilar insulin product
On July 28, 2021, FDA approved insulin glargine-yfgn (Semglee—Mylan Pharmaceuticals), the first interchangeable biosimilar insulin product. Semglee is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes.
“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, MD. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”
The approval of Semglee as an interchangeable biosimilar to its reference product Lantus is based on evidence demonstrating that the products are highly similar and that there are no clinically meaningful differences between the two products in terms of safety, purity, and potency. The data also found that Semglee can be expected to produce the same clinical result as Lantus in any given patient and that the risks in terms of safety or reduced efficacy of switching between Semglee and Lantus are not greater than the risk of using Lantus without switching.
Semglee is available in 10 mL vials and 3 mL prefilled pens and is administered subcutaneously once daily. Dosing of Semglee, like Lantus, should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine products. Also, like Lantus, Semglee is not recommended for treating diabetic ketoacidosis. Semglee may cause serious adverse effects, including hypoglycemia, severe allergic reactions, hypokalemia, and heart failure. The most common adverse effects associated with insulin glargine products other than hypoglycemia include edema, lipodystrophy, weight gain, and injection site allergic reactions.
FDA approves first interchangeable biosimilar insulin product
On July 28, 2021, FDA approved insulin glargine-yfgn (Semglee—Mylan Pharmaceuticals), the first interchangeable biosimilar insulin product. Semglee is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes.
“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, MD. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”
The approval of Semglee as an interchangeable biosimilar to its reference product Lantus is based on evidence demonstrating that the products are highly similar and that there are no clinically meaningful differences between the two products in terms of safety, purity, and potency. The data also found that Semglee can be expected to produce the same clinical result as Lantus in any given patient and that the risks in terms of safety or reduced efficacy of switching between Semglee and Lantus are not greater than the risk of using Lantus without switching.
Semglee is available in 10 mL vials and 3 mL prefilled pens and is administered subcutaneously once daily. Dosing of Semglee, like Lantus, should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine products. Also, like Lantus, Semglee is not recommended for treating diabetic ketoacidosis. Semglee may cause serious adverse effects, including hypoglycemia, severe allergic reactions, hypokalemia, and heart failure. The most common adverse effects associated with insulin glargine products other than hypoglycemia include edema, lipodystrophy, weight gain, and injection site allergic reactions.