Dermatology

A 48-year-old man presents with severe atopic dermatitis that he’s had since childhood. Can allergy shots succeed where standard treatments failed?

Here’s a round-up of recent designations granted by the FDA to products developed to treat rare diseases.

In a real-world setting, omalizumab improved UAS scores, DLQI scores, response scores, and saw a similar or better safety profile.

The FDA has extended the approved use of Bryhali (halobetasol propionate) Lotion .01% for up to 8 weeks in adults with plaque psoriasis.

The FDA has accepted Sanofi’s supplemental biologics license application (sBLA) for priority review of dupilumab (Dupixent) in patients aged 12 to 17 years with moderate-to-severe atopic dermatitis.

Patients treated with the RECELL Systems were required to donate 97.5% less skin than standard-of-care, and reported statistically significant reduction in patient-reported pain, increases in satisfaction, and improved outcomes in donor scars.

The patient population tends to have a more unbalanced immune profile to that of European American patients, indicating a potential for tailored treatment options to combat inflammation.

Novartis reported that 59% of patients at 24 weeks experienced little to no impact of their condition on their quality of life. Additionally, 87% of bio-naïve psoriasis patients remained on secukinumab through 12 months, indicating its tolerability in real-world settings.

The FDA has granted an orphan drug designation to Syntimmune Inc.’s SYNT001 for the treatment of pemphigus.

The FDA has granted a fast track designation to Immune Pharmaceuticals, Inc.’s bertilimumab for the treatment of bullous pemphigoid.

Altreno is a lotion containing .05% tretinoin, a retinoid that reduces inflammation and lesions associated with acne vulgaris.

Diacerein 1% ointment (CCP-020) received a fast track designation from the FDA for the treatment of epidermolysis bullosa simplex.

Krystal Biotech’s KB105 has received an orphan drug designation by the FDA for the treatment of patients with transglutaminase 1 deficient autosomal recessive congenital ichthyosis.

In a trio of phase 3 studies, omadacycline met the FDA-designated primary and secondary efficacy outcomes while reporting consistent safety measures and tolerability.

The first human clinical trial to assess RNA therapy, QR-313, for the treatment of recessive dystrophic epidermolysis bullosa has been initiated.

The virus was deemed eradicated by the World Health Organization in 1980. But there remains public concern of its use as a bioweapon.

The fixed-dose combination therapy from Valeant Pharmaceuticals International is vying to become the first and only approved topical lotion for the condition.