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Monthly News Roundup - July 2020

FDA Approves Wynzora Cream for Adults with Plaque Psoriasis

Plaque psoriasis is a chronic skin condition often found on the elbows, knees, scalp and lower back. It is characterized by raised, red lesions with a silvery white scale that may itch, burn or bleed.

  • In response, the FDA has approved Wynzora Cream (calcipotriene and betamethasone dipropionate), a vitamin D analog and corticosteroid treatment from MC2 Therapeutics. Wynzora is applied topically once daily in adults, not more than 100 grams per week, for up to 8 weeks.
  • In a phase 3 comparative study, Wynzora cream was non-inferior (effectiveness not worse than) compared to Taclonex (calcipotriene and betamethasone dipropionate) topical suspension at week 8 for the primary endpoint of treatment success.
  • The most common side effects for Wynzora compared to the vehicle included: upper respiratory infection (7% vs. 5%), headache (2% vs. 0%), and application site irritation (1% vs. 0%), respectively.

AstraZeneca’s Triple Drug Inhaler Breztri Aerosphere Cleared for COPD

In July, the FDA approved AstraZeneca’s Breztri Aerosphere, a metered dose inhaler for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). COPD is a long-term lung disease that includes chronic bronchitis, emphysema, or both.

  • Breztri combines an inhaled corticosteroid (budesonide 160 mcg) with an anticholinergic agent (glycopyrrolate 9 mcg) and a long-acting beta2-adrenergic agonist (formoterol fumarate 4.8 mcg) per inhalation. It is given as two inhalations twice daily.
  • Approval was based on positive results from the Phase 3 ETHOS and KRONOS trials. In ETHOS, a significant reduction in the rate of the primary endpoint, moderate or severe exacerbations, was seen compared with dual-combination therapies Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) and PT009 (budesonide and formoterol fumarate).
  • Breztri Aerosphere is not used for the treatment of asthma or acute bronchospasm.

FDA OKs Hulio, the Sixth Biosimilar to Humira

Hulio (adalimumab-fkjp) is a tumor necrosis factor (TNF) blocker and now the 6th biosimilar to AbbVie's Humira (adalimumab).

  • Hulio is approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Hulio will come in both a prefilled syringe and an auto-injector.
  • Hulio carries a Boxed Warning for an increased risk of serious infections leading to hospitalization or death, such as tuberculosis (TB), bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens.
  • In accordance with patent holder AbbVie, Mylan will launch Hulio in the U.S. during July 2023.
  • Other recently approved biosimilars to adalimumab include Abrilada from Pfizer (2019), Hadlima from Samsung Bioepis (2019), and Hyrimoz from Sandoz (2018).

ViiV’s First-in-Class HIV Drug Rukobia Cleared for Patients With Few Treatment Options

In July, the US Food and Drug Administration (FDA) approved the novel HIV treatment, Rukobia (fostemsavir). It is a 600 mg extended-release tablet taken twice daily with or without food.

  • Rukobia is used in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection. These patients are failing their current ARV regimen due to resistance, intolerance or safety concerns.
  • Rukobia is a prodrug of temsavir and is classified as a gp120-directed attachment inhibitor. It blocks HIV from attaching to CD4+ T-cells.
  • Approval was supported by the BRIGHTE Phase 3 study where 60% (n=163/272) of those who received Rukobia plus optimized background therapy achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through Week 96.
  • The most commonly reported side effect was nausea (10%).

FDA Approves Kite’s Tecartus CAR-T Cell Therapy for Mantle Cell Lymphoma

Kite, a Gilead Company, has received FDA-approval for it’s second chimeric antigen receptor (CAR) T cell therapy, Tecartus (brexucabtagene autoleucel).

  • Chimeric antigen receptor (CAR) T-cell therapy is a form of immunotherapy that uses a patient’s own genetically modified T cells to find and kill cancer cells.
  • Tecartus, a CD19-directed genetically modified autologous T cell immunotherapy, is the first CAR-T approval for treatment of adults with relapsed or refractory mantle cell lymphoma (MCL), a rare, aggressive form of non-Hodgkin lymphoma (NHL).
  • Approval was based on the ongoing ZUMA-2 study in which 87% of patients (n=60) responded to a single infusion of Tecartus, including 62% of patients who achieved a complete response. Median duration of response has not yet been reached.
  • Among 82 patients, 18% experienced Grade 3 or higher cytokine release syndrome (CRS) and 37% experienced Grade 3 or higher neurologic toxicities. Tecartus carries a Boxed Warning for CRS and neurologic toxicities, and is accompanied by a Risk Evaluation and Mitigation Strategy (REMS).
  • Other approved CAR-T cell therapies include Kite’s Yescarta (axicabtagene ciloleucel) and Novartis’ Kymriah (tisagenlecleucel).

Posted: July 2020