Firmagon regulatory update

The U.K.’s NICE will reconsider an April final appraisal determination (FAD) for Firmagon degarelix from Ferring after an agency panel upheld an appeal by the company. The FAD recommended Firmagon to treat advanced hormone-dependent prostate cancer only in a subgroup of patients with spinal metastases who present signs or symptoms of spinal cord compression. At a June 25 hearing, the panel decided that the way in which the FAD was issued was “unfair” and “lacked transparency.”

The appeal panel agreed with Ferring’s assertion that the wording of the proposed guidance “changed significantly” between December draft guidance and the April FAD without re-consultation and thus lacked transparency. The draft guidance recommended Firmagon for patients “at risk of impending spinal cord compression,” while the FAD recommended use in patients who “present with signs or symptoms of spinal cord compression” (see BioCentury, Jan. 6 & April 21). According to Ferring, the change in wording reduced the patient group eligible to receive the drug by 85%, to 520 per year from 3,520. ...