Monthly News Roundup – June 2022

Skyrizi Approved with On-Body Injector for Treatment of Crohn’s disease

Skyrizi (risankizumab-rzaa) works to reduce inflammation by binding to excess interleukin-23 (IL-23), a cytokine involved in several immune-mediated conditions. In June, the FDA approved Skyrizi to treat moderately to severely active Crohn’s disease in adults. Skyrizi is also approved to treat plaque psoriasis and psoriatic arthritis in adults.

  • In Phase 3 studies as early as week 4 in the induction studies, clinical response and remission were achieved by significantly more subjects treated with Skyrizi versus placebo, as were the co-primary endpoints of endoscopic response and clinical remission at week 12 and week 52.
  • For treatment of Crohn’s disease, the dosing schedule is three intravenous (IV) starter doses given 4 weeks apart (at Week 0, 4 and 8), then a subcutaneous (under the skin) injection given at Week 12, followed by an injection every 8 weeks thereafter.
  • After completing the initial intravenous starter doses, patients will receive Skyrizi as a subcutaneous injection using the prefilled cartridge with an on-body injector. Patients will be able to administer this at home after training from a healthcare provider. The injection dose is delivered in 5 minutes.
  • Skyrizi warnings and precautions include allergic reactions, increased risk of infection, and liver toxicity (in Crohn’s Disease). Common adverse reactions in Crohn’s Disease patients include upper respiratory infections, headache, joint pain, injection site reactions, and abdominal pain, among others.

Dupixent Pediatric Population Expanded for Atopic Dermatitis

In June, the FDA ​​expanded the patient population for Dupixent ​​(dupilumab) to include treatment of moderate-to-severe atopic dermatitis (eczema) in children 6 months to 5 years of age. The biologic can now be used for the treatment of both adult and pediatric patients aged 6 months and older with atopic dermatitis.

  • Approval is based on a Phase 3 study in 161 children evaluating Dupixent every 4 weeks plus low-potency topical corticosteroids (TCS) or TCS alone (placebo). At 16 weeks, patients who received Dupixent with TCS met the primary endpoint: 28% achieved clear or almost-clear skin compared to 4% with placebo, the primary endpoint.
  • The co-primary endpoint was also met: 53% on Dupixent achieved ≥ 75% improvement in overall disease severity compared to 11% with placebo TCS alone. Meaningful itch reduction was also achieved (48% vs. 9%).
  • The recommended dose is based on body weight and is given as one 200 or 300 mg subcutaneous (under the skin) injection every 4 weeks by prefilled syringe.
  • The most common adverse effects for this use are: injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.
  • Dupixent, an interleukin-4 receptor alpha antagonist from Regeneron / Sanofi, is also approved for the treatment of asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and eosinophilic esophagitis in various age groups.

Amvuttra: A New RNAi Therapeutic Given Quarterly to Treat hATTR Amyloidosis

Polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis is a rare, debilitating and often fatal genetic disease caused by mutations in the TTR gene. It leads to buildup of an abnormal amyloid protein in the nerves, heart and other organs. In people with hATTR amyloidosis, the median survival is 4.7 years following diagnosis and 3.4 years for patients presenting with cardiomyopathy.

  • In response, the FDA has cleared Amvuttra (vutrisiran), an RNAi therapeutic for hATTR amyloidosis in adults. Amvuttra, from Alnylam Pharmaceuticals, is designed to target and silence specific messenger RNA, blocking the production of the TTR protein.
  • Approval is based on 9-month results from the HELIOS-A Phase 3 study with 164 patients. Amvuttra significantly improved polyneuropathy with over 50% of patients experiencing improvement in neuropathy impairment relative to baseline.
  • The recommended dosage of Amvuttra is 25 mg given by subcutaneous (under the skin) injection once every 3 months.
  • The most common adverse reactions (≥5%) were arthralgia (joint pain, 11%), dyspnea (shortness of breath, 7%), and a decrease in vitamin A levels (7%). Supplementation with vitamin A at the recommended daily allowance (RDA) is advised for patients.

FDA Approves Priorix Live Vaccine for the Prevention of Measles, Mumps and Rubella

This month the FDA cleared GSK’s Priorix, a live, attenuated vaccine for measles, mumps and rubella (MMR) in people 12 months of age and older. Priorix is currently licensed in more than 100 countries worldwide. Priorix will provide US healthcare professionals with another choice for an MMR vaccine.

  • In recent years, measles outbreaks have occurred in the US and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress. The CDC recommends children should get two doses of MMR vaccine, starting with the first dose at 12 through 15 months of age, and the second dose at 4 through 6 years of age. Teens and adults should also be up to date on their MMR vaccination.
  • The efficacy of Priorix was demonstrated based on immunogenicity data versus the comparator vaccine. Each dose is given as 0.5 mL subcutaneous (under the skin) injection. The first dose is given at 12 through 15 months of age, and the second dose is administered at 4 through 6 years of age.
  • In six clinical safety studies, over 12,000 participants received at least one dose of Priorix. The most commonly reported adverse reactions were pain, redness, swelling, loss of appetite, irritability, drowsiness and fever. Do not use during pregnancy and avoid pregnancy for 1 month following vaccination.

FDA Approves Fylnetra (pegfilgrastim-pbbk), the 5th Biosimilar to Neulasta

In June the FDA approved Fylnetra (pegfilgrastim-pbbk), a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim), used to reduce the incidence of neutropenia in patients undergoing chemotherapy. Flynetra is from Amneal Pharmaceuticals.

  • Fylnetra is indicated to decrease the incidence of febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • It is administered subcutaneously (under the skin) via a single-dose prefilled syringe. Common side effects include bone pain and pain in extremities.
  • Fylnetra is the fifth FDA-approved pegfilgrastim biosimilar, after the approvals of Nyvepria (pegfilgrastim-apgf), Ziextenzo (pegfilgrastim-bmez), Udenyca (pegfilgrastim-cbqv) and Fulphila (pegfilgrastim-jmdb).

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