Nearly three years after an FDA rejection of Eagle Pharmaceuticals Inc.'s initial effort to add exertional heat stroke (EHS) to the list of approved indications for Ryanodex (dantrolene sodium), its efforts have again been met with a complete response letter. The calcium channel modulator is already approved for the treatment of malignant hyperthermia (MH), but Eagle said it has decided to drop further pursuit of EHS.
The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch.
Two weeks after receiving a letter from the FDA citing deficiencies in the NDA seeking approval for VP-102 (cantharidin 0.7% topical solution) in molluscum contagiosum, Verrica Pharmaceuticals Inc. disclosed an unsurprising complete response letter.
The FDA sent a complete response letter (CRL) to Allergan plc, an Abbvie Inc. company, and Molecular Partners AG, of Zurich, Switzerland, regarding the BLA for abicipar pegol, their VEGF-A inhibitor-Darpin therapy for patients with wet age-related macular degeneration (AMD).
Not long after a morning earnings call on March 27 in which Intelgenx Corp. CEO Horst Zerbe said his team was still awaiting word from the FDA on its resubmitted 505(b)(2) application for its acute migraine candidate, Rizaport Versafilm, that news arrived in the form of a complete response letter (CRL), its third following earlier CRLs in February 2014 and April 2019.