Monthly Archives: May 2022

Tpoxx® (tecovirimat – SIGA Technologies) has received an expanded smallpox treatment indication, as well as FDA approval of a new dosage formulation. Tpoxx is now approved for pediatric patients who weigh as little as 3kg (6.6 pounds) and comes in oral capsule and intravenous formulations.

• The U.S. FDA approved Tpoxx oral capsules in 2018 to treat human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13kg (28.7 pounds). The new intravenous solution allows Tpoxx to be used in patients who are unable to swallow capsules.
• Recommended dosing is based on the patient’s age, weight, and ability to swallow capsules.
• Although naturally occurring smallpox has been eradicated since 1980, the disease remains of concern to the U.S. FDA as a potential bioweapon.

May 17, 2022 – The U.S. FDA has expanded emergency use authorization (EUA) for Comirnaty® (COVID- 19 vaccine, mRNA), made by Pfizer and BioNTech. The product is now authorized for use as a single booster dose for individuals 5-11 years old.

• The booster dose is authorized in children who have completed a primary vaccination series with Comirnaty at least five months prior.
• Comirnaty has been authorized since January 3, 2022, for use as a booster dose in individuals who are at least 12 years old.

Dupixent® (tirzepatide) has become the first drug to win FDA approval specifically for treating eosinophilic esophagitis (EoE). It is indicated to treat EoE in adults and in pediatric patients who are at least 12 years old and weigh at least 40kg (88 pounds).

• EoE is a chronic autoimmune disease that causes an inflammatory response in the esophagus, a muscular tube that carries food and drink from the throat to the It can lead to difficulty swallowing and eating, and can cause food to become trapped in the esophagus.
• Dupixent first received FDA approval in 2017 to treat atopic dermatitis, a chronic inflammatory skin disease. It has since gained indications for asthma and for chronic rhinosinusitis.
• Recommended dosing for EoE is 300mg via subcutaneous injection once Dupixent can be self-administered or administered by a caregiver or healthcare provider.

Eli Lilly’s Mounjaro™ (tirzepatide) has received FDA approval for use alongside diet and exercise to improve blood sugar control in adults who have type 2 diabetes.

• A first-in-class treatment, Mounjaro activates the GLP-1 and GIP receptors in the body to improve blood sugar control.
• The recommended starting dose is 2.5mg administered via subcutaneous injection once weekly, with the dose increased to 5mg once weekly after four weeks. If additional glycemic control is required after another four weeks, the dosage can be increased in increments of 2.5mg, up to a maximum of 15mg once weekly.
• Mounjaro has launched at a wholesale acquisition cost (WAC) of $974.33 per month.

Sandoz has launched the first fully substitutable generic for Genentech’s Esbriet® (pirfenidone) tablets. Esbriet is also available in capsule form, for which there is currently no generic.

• Esbriet and its generic are indicated to treat idiopathic pulmonary fibrosis, a rare disease that causes scarring of the lungs, making breathing difficult.
• The recommended starting dose is 267mg three times daily for Days 1-7. This is then titrated to 534mg three times daily on Days 8-14, before being increased to a maintenance dose of 801mg three times daily from Day 15 onward. Pirfenidone should be taken with food.
• Sandoz’s generic is available at a wholesale acquisition cost (WAC) of $9,130.57 per 30-day supply, while the WAC for a 30-day supply of brand name Esbriet tablets is $10,449.43.

Radicava ORS® (edaravone – Mitsubishi Tanabe Pharma America), has received FDA approval to treat amyotrophic lateral sclerosis (ALS) in adults.

• The product is a new oral suspension version of Radicava, a drug that first received FDA approval to treat ALS in 2017. Radicava is approved only for intravenous use.
• Recommended dosing for Radicava ORS is 105mg (5mL) administered by mouth or via feeding tube. The medication is taken in the morning after overnight fasting. For one hour following administration, patients should consume no food and should only drink water.
• Administration of both Radicava and Radicava ORS follows the following schedule:
  • Initial treatment cycle: Daily dosing for 14 days followed by a 14-day drug-free period.
  • Subsequent treatment cycles: Daily dosing for 10 days out of each 14-day period, followed by 14-day drug-free periods.
• The wholesale acquisition cost of Radicava ORS is $12,719.30 per 28-day supply.

Olumiant® (baricitinib – Eli Lilly and Incyte) is now approved to treat COVID-19 in hospitalized adults who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

• In 2020, the U.S. FDA granted emergency use authorization (EAU) for Olumiant to be used alongside Veklury® (remdesivir – Gilead) to treat COVID-19 in certain patients. An EUA is still in effect for Olumiant’s use in the treatment of hospitalized pediatric patients at least two years of age who require oxygen support.
• Recommended dosing under the new FDA approval for adults is 4mg once daily for 14 days or until hospital discharge, whichever comes first.

Due to potential for rare but serious blood clots, the FDA has limited emergency use authorization (EAU) for Janssen’s COVID-19 vaccine.

• The vaccine initially received an EUA in February 2021 to prevent COVID-19 in individuals at least 18 years of age. It is now only authorized to prevent COVID-19 in:
  • Individuals at least 18 years old for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate.
  • Individuals at least 18 years old who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
• The FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but life-threatening condition observed in some recipients of the vaccine, warrants limiting the product’s authorized use.

The U.S. FDA has granted regular approval to Enhertu® (fam-trastuzumab deruxtecan-nxki) as a treatment for unresectable or metastatic HER2-positive breast cancer in adults who have received a prior anti-HER2-based regimen (in the metastatic setting or in the neoadjuvant or adjuvant setting) and have developed disease recurrence during or within six months of completing therapy.

• Enhertu initially received accelerated approval for this indication in Continued approval was contingent upon the results of confirmatory trials. Enhertu won regular approval based on data from the DESTINY-Breast03 randomized trial.
• The drug is also approved to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adults.
• Recommended dosing for breast cancer is 5.4mg/kg administered via intravenous infusion once every three weeks (21-day cycle) until disease progression or unacceptable toxicity occur.

Phathom Pharmaceuticals’ Voquezna™ Triple Pack (vonoprazan/amoxicillin/clarithromycin) and Voquezna™ Double Pack (vonoprazan/amoxicillin) have been approved to treat Helicobacter pylori infection in adults.

• H. pylori bacteria cause infections in the stomach and duodenum (first part of the small intestine) and are the main cause of peptic ulcers. Voquezna Triple Pack and Double Pack co-package antibiotics with a novel acid-blocking medication, vonoprazan, to treat such infections.
• The recommended dosing is as follows:
  • Voquezna Triple Pack: Vonoprazan 20mg, amoxicillin 1,000mg, and clarithromycin 500mg each taken twice daily (12 hours apart) for 14 days.
  • Voquezna Double Pack: Vonoprazan 20mg taken twice daily plus amoxicillin 1,000mg taken three times daily (morning, mid-day, and evening) for 14 days.
• Both Voquezna Triple Pack and Voquezna Double Pack have a wholesale acquisition cost of $812 per treatment course.