PDR Drug Update - October 2023

Viral Skin Infection Has New Therapeutic Treatment

The highly contagious and yet underdiagnosed viral skin infection known as molluscum contagiosum is experienced by approximately 6 million individuals per year in the US. The lesions caused by the poxvirus can be extremely irritating and prone to strong inflammation. Patients have been known to live with molluscum lesions for multiple years, coping with pruritus and becoming susceptible to bacterial infection and permanent scars. A newly approved therapy may offer some relief for this condition.

Molluscum contagiosum is characterized by papules of one millimeter to one centimeter in size that appear on the skin and are usually rounded and dome-shaped with a white, flesh-tone, purple, or pink hue. Transmission of the lesions can occur indirectly via razors, toys, linens, or other objects that come in close contact with the body or through direct skin-to-skin contact. Scratching or otherwise injuring the lesions can cause autoinoculation, spreading the infection to nearby skin. Young children are the most frequently diagnosed individuals, but teens and adults can also become infected, especially those who are immunocompromised. Children who have eczema also seem to be particularly vulnerable.

After contracting the virus, the first signs of papules emerge between two and eight weeks later. They begin small and typically grow larger, forming a dome with a center indentation. A molluscum contagiosum infection typically ranges from six to 12 months but can last as long as five or more years. Most healthy patients can clear the infection in under two years spontaneously with no treatment. A healthcare team should work with the patient to determine the care approach for a molluscum contagiosum infection. Treatment options will vary depending on the patient preference, other health issues, papule locations, risk of transmission, and other circumstances. Sometimes, physical removal is the chosen treatment method. This may include healthcare provider-administered cryotherapy, curettage, and laser therapy. Oral and topical therapies are also potential options for gradually reducing the lesions. However, until now, no FDA-approved treatment has been available for the virus.

The new approval is a proprietary drug-device combination containing a GMP-controlled formulation of cantharidin (inactive ingredients include gentian violet to help mark treated lesions and denatonium benzoate as an oral deterrent to help avoid accidental ingestion). Marketed as Ycanth (cantharidin) topical solution, the product is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients aged two years and older. The drug demonstrated its efficacy through two clinical trials, with 54% of patient participants treated with Ycanth achieving complete clearance of all treated papules by day 84. Just 13% of patients treated with placebo in the study achieved these results.

Patients, caregivers, and healthcare providers can all benefit from advancements such as new treatment options like Ycanth. As medical dermatology therapies continue to evolve, stay informed about critical drug information, including targeted therapies for poxviruses, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, available for free from your preferred app store.

FDA New Approvals

Aphexda

The FDA has approved Aphexda (motixafortide) in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. Aphexda is administered by injection for subcutaneous use. Learn more about Aphexda

Bimzelx

The FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimzelx is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes–interleukin 17A and interleukin 17F. Learn more about Bimzelx

Cabtreo

The FDA has approved Cabtreo (adapalene/benzoyl peroxide/clindamycin phosphate) topical gel 0.15%/3.1%/1.2% indicated for the topical treatment of acne vulgaris in patients aged 12 years and older. Cabtreo is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne. Learn more about Cabtreo

Combogesic IV

The FDA has approved Combogesic IV (acetaminophen/ibuprofen) injection for intravenous (IV) use in adults where an IV route of administration is considered clinically necessary for the relief of mild-to-moderate pain or the management of moderate to severe pain as an adjunct to opioid analgesics. Learn more about Combogesic IV

Exxua

The FDA has approved Exxua (gepirone HCl) extended-release tablets for the treatment of major depressive disorder in adults. Exxua represents a new class of antidepressant; the first and only approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion. Learn more about Exxua

Ojjaara

The FDA has approved Ojjaara (momelotinib) for the treatment of intermediate- or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythemia), in adults with anemia. Learn more about Ojjaara

Penbraya

The FDA has approved Penbraya (meningococcal groups A, B, C, W, and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults aged 10 through 25 years. Learn more about Penbraya

Rivfloza

The FDA has approved Rivfloza (nedosiran) injection 80mg, 128 mg, and 160 mg, a once-monthly subcutaneous ribonucleic acid interference therapy, to lower urinary oxalate levels in children aged 9 years and older and adults with primary hyperoxaluria type 1 and relatively preserved kidney function. Learn more about Rivfloza

Ryzumvi

The FDA has approved Ryzumvi (phentolamine) 0.75% ophthalmic solution for the treatment of pharmacologically induced mydriasis produced by adrenergic agonists (eg, phenylephrine) or parasympatholytic (eg, tropicamide) agents. Learn more about Ryzumvi

Tofidence

The FDA has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra. The Tofidence intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Learn more about Tofidence

Velsipity

The FDA has approved Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for adults with moderately to severely active ulcerative colitis. Learn more about Velsipity

Xphozah

The FDA has approved Xphozah (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. Xphozah is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway. Learn more about Xphozah

Zilbrysq

The FDA has approved Zilbrysq (zilucoplan) for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. Learn more about Zilbrysq

FDA New Indications

Keytruda

The FDA has approved Keytruda for the treatment of patients with resectable (tumors ≥4cm or node-positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. With this approval, Keytruda has six indications in NSCLC across both metastatic and earlier stages of NSCLC. Learn more about Keytruda

Opdivo

The FDA has approved Opdivo (nivolumab) for the adjuvant treatment of adult and pediatric patients aged 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication. Learn more about Opdivo

Voxzogo

The FDA has approved Voxzogo (vosoritide) to increase linear growth in pediatric patients with achondroplasia with open epiphyses (growth plates). This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Previously, Voxzogo was indicated for children aged 5 years and older. This expanded indication now includes children of all ages with open growth plates. Learn more about Voxzogo

FDA New Combinations

Braftovi + Mektovi

The FDA has approved Braftovi (encorafenib) + Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test. BRAF V600E mutations can be assessed from either plasma or tumor tissue using the FoundationOne Liquid CDx or the FoundationOne CDx FDA-approved companion diagnostic tests, respectively. Learn more about Braftovi + Mektovi

Pombiliti + Opfolda

The FDA has approved Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) 65mg capsules. This two-component therapy is indicated for adults living with late-onset Pompe disease weighing ≥40kg and who are not improving on their current enzyme replacement therapy. Learn more about Pombiliti + Opfolda

FDA New Formulations

Cosentyx

The FDA has approved an intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A and the only non-tumor necrosis factor alpha IV option available in all these indications. Learn more about Cosentyx

Entyvio

The FDA has approved a subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis after induction therapy with Entyvio intravenous. Learn more about Entyvio

Likmez

The FDA has approved a liquid reformulation of the antibiotic metronidazole, metronidazole oral suspension 500mg/5mL (ATI-1501). ATI-1501 has been licensed for commercialization in the US and other selected territories. The FDA also approved Likmez as the brand name for ATI-1501. Learn more about Likmez

FDA Recalls

Biomic Sciences Nasal Sprays

Biomic Sciences is voluntarily recalling all lots of Ion Sinus Support, Ion Sinus, and Restore Sinus Spray products to the consumer level. FDA testing found the product to contain microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp. (primarily B. malikii), and Paenibacillus sp. (these microorganisms are generally non-pathogenic). Learn more about the Biomic Sciences nasal sprays recall

Botanical-Be Dietary Supplements

Botanical-Be is voluntarily recalling all lots of Kuka Flex Forte, Artri King, and Reumo Flex capsules to the consumer level. FDA analysis has found the capsules to be tainted with diclofenac. Diclofenac is an approved non-steroidal anti-inflammatory drug. Its presence in the products renders them unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall. Learn more about the Botanical-Be dietary supplements recall

Church & Dwight Oral Rinse

Church & Dwight Co. initiated a voluntary recall of one specific lot of TheraBreath Strawberry Splash for Kids 16oz after identifying microbial contamination due to the presence of yeast (Candida parapsilosis) in lot #PA3083011 of TheraBreath Strawberry Splash for Kids 16oz to the consumer level and sold exclusively on Amazon between May 31 and September 02, 2023. Learn more about the Church & Dwight oral rinse recall

Exela Pharma Sciences Products

Exela Pharma Sciences is voluntarily recalling multiple products to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples. The products include 8.4% sodium bicarbonate injection, USP, 50mEq/50mL, 5mL single-dose vial; midazolam in 0.8% sodium chloride injection, 100mg/100mL, 100mL single-dose vial; and Elcys (cysteine HCl) injection, USP, 500mg/10mL, 10mL single-dose vial. Learn more about the Exela Pharma Sciences products recall

Family Dollar Products

Family Dollar is initiating a voluntary retail-level product recall of certain over-the-counter drugs and medical devices regulated by the FDA. These items were stored outside of labeled temperature requirements by Family Dollar and inadvertently shipped to certain stores on or around June 1, 2023 through September 21, 2023. These items were sold at those stores between June 1, 2023 and October 4, 2023. Learn more about the Family Dollar products recall

Hospira Products

Hospira, Inc., a Pfizer company, is voluntarily recalling certain lots of 4.2% sodium bicarbonate injection, USP, 5mEq/10mL vial; 1% lidocaine HCl injection, USP, 50mg/5mL vial; and 2% lidocaine HCl injection, USP, 100mg/5mL vial to the user level. The recall was initiated due to the potential for the presence of glass particulate matter. Learn more about the Hospira products recall

KVK Tech Betaxolol Tablets

KVK-Tech, Inc. is voluntarily recalling one lot (batch number: 17853A) of betaxolol tablets, USP 10mg, to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single oxycodone HCl 5mg foreign tablet found on the packaging line during the line clearance after the subject batch was packaged. Learn more about the KVK Tech betaxolol tablets recall

Novartis Sandimmune Oral Solution

Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune (cyclosporine) oral solution, USP, 100mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. Learn more about the Novartis Sandimmune oral solution recall

Scynexis Brexafemme

Scynexis, Inc. is conducting a voluntary nationwide recall of two lots of Brexafemme (ibrexafungerp) tablets to the consumer level in the US market due to potential cross-contamination with a non-antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the tablets. Learn more about the Scynexis Brexafemme recall

VistaPharm Sucralfate Oral Suspension

VistaPharm is voluntarily recalling one lot of sucralfate oral suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the. Learn more about the VistaPharm sucralfate oral suspension recall

FDA Alerts

Prograf Generics

Based on new data, the FDA is changing the therapeutic equivalence rating for tacrolimus oral capsule products manufactured by Accord Healthcare Inc. under the abbreviated new drug application 091195. These drugs are indicated for the prevention of organ rejection in adult patients receiving kidney, liver, or heart transplants, and in pediatric patients receiving liver transplants. The FDA is concerned that the peak blood concentration of tacrolimus for Accord Healthcare Inc.’s generic tacrolimus oral capsules may be increased compared to the brand-name drug, Prograf (tacrolimus), creating a risk of toxicity. However, according to the new data, there were no significant differences in the trough blood levels, indicating no increased risk for organ rejection. Learn more about the Prograf generics safety statement

Labeling Updates - No Updates this Month

Key
Boxed Warning
Other Warnings*

*Warnings and Precautions; Adverse Reactions; Drug Interactions; and Contraindications
Updates to Indications/Dosage
Other Updates†

†Other labeling changes; added to PDR database