Sedor’s Sesquient Received the US FDA’s Approval for Status Epilepticus
Published: Nov 09, 2020 | Tags: Sedor Pharmaceuticals, US FDA approval, Sesquient, Treatment, Status Epilepticus, Adult and Pediatric patients
- The US FDA has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients
- Sedor is actively in discussions to license the rights to Sesquient for NA, EU, and other territories, except for the People’s Republic of China, where it has already been licensed
- Sesquient is the first and only FDA-approved room temperature stable fosphenytoin and can help HCPs to treat status epilepticus patients and reduce hospital costs associated with this condition
Published: Nov 20, 2020 | Tags: approval, Deficient, Eiger, lonafarnib, PL, Processing, Progeria, receives, Treatment Us FDA, Zokinvy
- The Progeria Research Foundation and Eiger reported the US FDA’s approval of Zokinvy (lonafarnib) for the treatment of HGPS or progeria and processing-deficient progeroid laminopathies
- Zokinvy reduced the incidence of mortality by 60% & increased the average survival time by 2.5 yrs. Additionally, the FDA has issued an RPD priority review voucher to Eiger
- Eiger plans to sell the PRV and will share the proceeds equally with PRF, under its supply & collaboration agreement. Zokinvy is a farnesyltransferase inhibitor that has shown a survival benefit in children with Progeria
Published: Nov 23, 2020 | Tags: Adult, Alnylam, approval, Hyperoxaluria, Lumasiran, OXLUMO, patients, Pediatric, Primary, receives, Treatment, Type 1, US FDA
- The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients
- The ILLUMINATE-A showed that Oxlumo met its 1EP i.e. change in 24hrs. (65% vs 12%) compared to PBO, the study also achieved significant results for all 6 tested 2EPs
- In ILLUMINATE-B, Oxlumo demonstrated a 72% mean reduction in spot urinary oxalate: creatinine ratio from baseline to 6mos., reduction of oxalate as consistent across all three body wt. categories. Additionally, therapy demonstrated positive results across 2EPs, including additional measures of oxalate
Published: Nov 24, 2020 | Tags: approval, baloxavir marboxil, Contact, Following, Infected, Influenza, Person, Prevention, receives, Roche, Us FDA, Xofluza
- The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test
- Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals
- Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person. Roche also plans to file sNDA for Xofluza as a treatment for acute uncomplicated influenza in pediatric patients (1-12yrs.) and for the prevention of influenza in the same age group who have been exposed to influenza
Y-mAbs’ Danyelza (naxitamab-gqgk) Received the US FDA’s Approval for Neuroblastoma
Published: Nov 25, 2020 | Tags: (naxitamab-gqgk), approval, Danyelza, Neuroblastoma, receives, US FDA, Y-mAbs Therapeutics
- The US FDA has approved Danyelza (40mg/10ml) and is indicated in combination with GM-CSF for pediatric patients aged 1yrs. & older and adult patients with r/r high-risk neuroblastoma in the bone marrow
- The indication is approved under accelerated approval regulation based on ORR and DOR. Continued approval for the indication may be contingent upon verification and description of clinical benefits in a confirmatory trial
- Danyelza is a mAb that targets the ganglioside GD2 which is highly expressed in various neuroectoderm-derived tumors and sarcomas and has received PR, ODD, BT and RPD from the US FDA
Published: Nov 27, 2020 | Tags: Rhythm, Pharmaceutical, IMCIVREE, setmelanotide, Receives, US FDA, Approval, Chronic, Weight, Management, Patients, Obesity
- The US FDA has approved Imcivree for chronic weight management in adult & pediatric patients aged ≥6yrs. with obesity due to POMC, PCSK1 or LEPR deficiency confirmed via genetic testing
- The approval is based on results of P-III trials that demonstrated 80% of patients with obesity due to POMC or PCSK1 deficiency achieved >10% weight loss & 45.5% of patients with obesity due to LEPR deficiency achieved >10% weight loss after 1yr of treatment
- The US FDA issued a Rare Pediatric Disease PRV to Rhythm with the approval. The PRV can be redeemed to receive PR for any marketing application or sold/ transferred to other companies for their programs. The therapy is under EMA’s review for approval
Related Post: Insights+: The US FDA New Drug Approvals in October 2020
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