FDA OKs New Molecular Entities from Novartis, Eli Lilly; AstraZeneca’s Self-Admin FasenraBy
Novartis, Eli Lilly respectively get FDA approval for wet-age macular degeneration and migraine drugs, and AstraZeneca gets approval for its asthma drug in a new product form, a prefilled auto-injector.
Novartis Gets FDA Approval for Wet-Age Macular Degeneration Drug Beovu
Novartis has received US Food and Drug Administration (FDA) approval for Beovu (brolucizumab-dbll) injection for treating wet age-related macular degeneration.
Beovu is a humanized single-chain antibody fragment functioning as VEGF (vascular endothelial growth factor) inhibitor.
FDA OKs Lilly’s Migraine Drug Reyvow
Eli Lilly and Company has received FDA approval for Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. The drug is not approved for the prevention of migraines.
Reyvow is an oral treatment that binds to 5-HT1F receptors.
AstraZeneca Receives FDA Approval for Self-Administered Asthma Drug Fasenra
AstraZeneca has received FDA approval for the self-administration of Fasenra (benralizumab), AstraZeneca’s respiratory biologic for treating severe eosinophilic asthma, in a prefilled, single-use auto-injector (the Fasenra Pen).
Fasenra self-administration and the Fasenra Pen are also approved in the European Union. Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, European Union, Japan and other countries.
Nestlé’s Galderma Laboratories Gains FDA Nod for Acne Drug Aklief
Galderma Laboratories, a research and development dermatology company and part of Nestlé Skin Health, has received FDA approval for Aklief (trifarotene) for the topical treatment of acne vulgaris in patients nine years of age and older.
Trifarotene is the first new retinoid molecule to receive FDA approval for the treatment of acne in more than 20 years, according to Galderma.
Clinuvel Receives FDA Approval for Pain-Free Light Exposure Drug Scenesse
Clinuvel Pharmaceuticals, a developer of treatments for severe genetic and skin disorders, has received FDA approval for Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage of the skin) from erythropoietic protoporphyria (EPP).
Clinuvel says Scenesse is the first global systemic photoprotective drug for the treatment of patients with EPP. Scenesse was approved for the prevention of phototoxicity in adult EPP patients in Europe in December 2014.
Scenesse is a melanocortin-1 receptor (MC1-R) agonist, which increases the production of eumelanin in the skin independent of exposure to sunlight or artificial light sources. It is an implant that is administered subcutaneously (inserted under the skin).
Feinstein Institutes Gains FDA OK for PET Diagnostic Agent
The Feinstein Institutes for Medical Research has received FDA approval for Fluorodopa F 18 injection, a radioactive diagnostic agent for use in positron emission tomography (PET), to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes.