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Weekly Drug News Round-Up: December 20, 2017

FDA Approves Luxturna Gene Therapy for Rare Form of Vision Loss

Luxturna is the first directly administered gene therapy that targets a disease caused by mutations in a specific gene Read More…

This week the FDA approved another novel gene therapy, Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics. Luxturna is used in patients with biallelic RPE65-mediated inherited retinal disease (IRD), a form of vision loss that can lead to blindness. Luxturna is an adeno-associated viral (AAV) vector gene therapy that delivers a normal copy of the RPEE65 gene directly to retinal cells. In a Phase III study with 31 participants, patients that received Luxturna had significant improvements in their ability to complete an obstacle course at low light levels as compared to the control group. Common side effects from the one-time treatment includes eye redness, cataracts, increased intraocular pressure and retinal tear.

FDA Clears Ixifi, a Biosimilar to Remicade

Biosimilar approvals continue to expand in the U.S. market; nine biosimilars are now available Read More...

Ixifi (infliximab-qbtx), from Pfizer, is a newly approved tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab). Ixifi is indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Approval is based on the totality of evidence demonstrating a high degree of similarity to the reference product, including the REFLECTIONS B537-02 study in patients with moderate to severe active rheumatoid arthritis. The study met its primary endpoint of ACR20 response ≥20% improvement at Week 14, and was supported by data at week 30. Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda) are also approved biosimilars to Remicade; however, none are interchangeable.

Rhopressa Approved for Open-Angle Glaucoma or Ocular Hypertension

Rhopressa is expected to be available commercially in the second quarter of 2018 Read More...

Glaucoma, often caused by an abnormally high pressure in the eye due to fluid build-up, can damage the optic nerve and lead to blindness. The FDA has approved Rhopressa (netarsudil ophthalmic solution) 0.02% once daily eye drop for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Rhopressa, from Aerie Pharmaceuticals, is a Rho kinase inhibitor. Rhopressa is believed to reduce IOP by increasing the outflow of aqueous humor (the fluid inside the eye) through the trabecular meshwork, the main fluid drain of the eye.

Eskata Topical Gains Approval for Treatment of Seborrheic Keratoses

Seborrheic keratosis is more prevalent than acne, psoriasis and rosacea combined Read More...

Seborrheic keratoses (SKs) are non-cancerous skin growths that affect more than 83 million American adults and can be cosmetic embarrassment. As a treatment option, the FDA has now approved  Eskata (hydrogen peroxide) 40% topical solution from Aclaris Therapeutics, a concentrated hydrogen peroxide formulation for raised SKs. Eskata is applied to the keratoses during an in-office procedure by a healthcare provider using a pen-like applicator. In studies, patients received up to two treatments with Eskata and were more likely to have all SKs completely cleared after two treatments than patients who received placebo. The most common side effects were itching, stinging, crusting, swelling, redness and scaling at the site of application.

Xepi 1% Topical Cream for Impetigo Soon Available

Xepi is the first new topical treatment for impetigo in more than 10 years Read More…

Impetigo is a highly contagious bacterial skin infection, often seen in infants and children. Xepi (ozenoxacin) Cream, 1%, is now approved as a treatment option for impetigo due to Staphylococcus aureus or Streptococcus pyogenes in patients two months of age and older. Xepi, a topical non-fluorinated quinolone, is applied topically twice daily for 5 days. In Phase III studies, Xepi showed excellent antibacterial activity against S. aureus and S. pyogenes, including methicillin-resistant S. aureus (MRSA). Bacterial success, defined as bacterial eradication or presumed eradication, was achieved in 90.8% of patients using Xepi versus 69.8% for placebo (p<0.0001) at the end of treatment. Availability is expected in the first quarter of 2018.