FDA Approvals Roundup: Remdesivir, Eysuvis, Sklice
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).New approvals
Remdesivir gets the go-ahead for COVID-19
Gilead Sciences’ Veklury (remdesivir) has been approved for the treatment of older children and adults who are hospitalized with COVID-19.
[SEE: Remdesivir receives FDA approval for COVID-19, Regulatory Focus, 22 October 2020]
New indications
Eysuvis okayed for short-term treatment of dry eye disease
Kala Pharmaceuticals’ Eysuvis (loteprednol etabonate ophthalmic suspension, 0.25%) has been approved as a short-term treatment for patients with dry eye disease. Loteprednol etabonate is already available in different formulations and strengths for treating other eye-related conditions.
Under the latest approval, the ophthalmic corticosteroid is indicated for use for up to 2 weeks by patients with dry eye disease. It is the first approved therapy for the chronic, difficult-to-manage condition, which is marked by unstable tear production resulting in ocular surface damage and inflammation, and visual disturbance.
Approval of Eysuvis was based on findings from four trials (three phase 3, one phase 2) showing improvements in disease signs and symptoms in patients receiving the study treatment. In all three phase 3 trials, statistical significance was reached 2 weeks from baseline for the sign endpoint of conjunctival hyperemia. Two of the phase 3 trials reported significance after 2 weeks for the endpoint of ocular discomfort severity, both among intent-to-treat patients and a predefined subgroup of patients who had more severe ocular discomfort at baseline. The therapy was well tolerated by patients in all four trials, with adverse events and increases in intraocular pressure comparable with control patients.
Eysuvis uses a mucus-penetrating particle drug delivery technology to facilitate absorption of loteprednol etabonate into the ocular surface tissue, where it subdues the immune responses that trigger the flares.
Sklice head lice treatment switched to OTC
Arbor Pharmaceuticals’ Sklice (ivermectin lotion, 0.5%) has been approved as a nonprescription or over-the-counter (OTC) topical treatment for head lice infestation in patients aged 6 months or older.
Sklice was originally approved as a prescription drug in the same formulation in 2012 for the same indication.
The process for changing from prescription to nonprescription status is known as a prescription-to-OTC, or RX-to-OTC, switch. The manufacturer usually initiates the switch to OTC and must present data supporting the product’s safety and efficacy when used according to proposed labeling directions. The manufacturer must also demonstrate the user will be able to understand how to administer the treatment without guidance from a healthcare professional.
One of the aims of the switch option is to improve public health by increasing access to therapies.