Regulatory

The UK's National Institute for Health and Care Excellence (NICE) has announced that it is not recommending the use of Janssen's Spravato esketamine nasal spray for the treatment of treatment-resistant depression due to concerns about clinical benefits and cost effectiveness. NICE will accept comments on the draft guidance through its web site until February 18, … [Read more...] about NICE declines to recommend Spravato nasal spray for the treatment of treatment-resistant depression

Liquidia Technologies said that it has submitted a 505(b)(2) NDA for its LIQ861 inhaled dry powder treprostinil for the treatment of pulmonary arterial hypertension (PAH). The company announced in March 2019 that the Phase 3 INSPIRE trial of LIQ861 had met its primary endpoint. Liquidia CEO Neal Fowler commented, "The submission of the NDA for LIQ861 in the US is … [Read more...] about Liquidia submits NDA for LIQ861 treprostinil DPI for the treatment of PAH

Health Canada has approved Baqsimi intranasal dry powder glucagon for the treatment of severe hypoglycemia in patients with Type 1 or Type 2 diabetes, Eli Lilly Canada has announced. Baqsimi is now available in Canadian pharmacies with or without a prescription. Lilly acquired worldwide rights to the intranasal glucagon formulation from Locemia, which is based in … [Read more...] about Baqsimi intranasal glucagon approved in Canada

According to Evoke Pharma, the FDA has accepted its resubmitted NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis and has set a PDUFA date of June 19, 2020. The original 505(b)(2) NDA was submitted in June 2018, and the FDA issued a complete response letter to that NDA in April 2019. Evoke announced in December 2019 that it had … [Read more...] about FDA accepts resubmitted NDA for Gimoti nasal spray

Janssen Pharmaceutical announced that the company has submitted a type II variation application for Spravato esketamine nasal spray to the EMA seeking to expand the use of Spravato for the treatment of major depressive disorder (MDD) in patients who have active suicidal ideation with intent. Spravato was approved in Europe in December 2019 for the treatment of … [Read more...] about Janssen submits type II variation application for Spravato

The FDA has approved Neurelis's Valtoco diazepam nasal spray for the treatment of seizure clusters or acute repetitive seizures in epilepsy patients aged 6 years and older. Neurelis submitted the 505(b)(2) NDA for Valtoco in September 2018. Valtoco, which was formerly known as NRL-1, was granted orphan drug designation in December 2015 and Fast Track designation in … [Read more...] about FDA approves Valtoco diazepam nasal spray for the treatment of seizure clusters

Seelos Therapeutics said that it has scheduled a Type C meeting with the FDA for March 2020 regarding a Phase 3 trial of its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior (ASIB) in patients with major depressive disorder (MDD). The FDA granted Fast Track designation to SLS-002 in November 2019. According to the … [Read more...] about Seelos Therapeutics sets Type C meeting with FDA regarding SLS-002 intranasal racemic ketamine

According to Savara, the FDA has granted Breakthrough Therapy designation for Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). In June 2019, Savara announced that the Phase 3 IMPALA study of Molgradex for that indication had failed to meet its … [Read more...] about FDA grants Breakthrough Therapy designation for Molgradex for aPAP