Thank you Ohm for your research in developing this list. Your work is exhaustive and appreciated.
Look however, how specific these medications are and how rare the majority of their indications are. Compare and Contrast that to our Leronlimab with 90 indications which are paramount amongst all of humanity. Then consider possibly, why the FDA let them slide.
Argenx - Vyvgart >> generalized myasthenia gravis (gMG)
Mirum Pharmaceuticals - Livmarli >> Indication: Treatment of cholestatic pruritis in patients with Alagille syndrome (ALGS)
Ascendis Pharma - Skytrofa >> human growth hormone indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)
Albireo Pharma - Bylvay >> treat skin itching caused by a certain inherited liver condition (progressive familial intrahepatic cholestasis-PFIC). In PFIC, a substance that your body normally makes (bilirubin) builds up in the liver and results in jaundice
Kadmon Corporation - Rezurock >> chronic graft-versus-host disease (chronic GVHD) after you have received at least 2 prior treatments (systemic therapy) and they did not work
SCYNEXIS - Brexafemme >> vaginal yeast infections
QED Therapeutics/BridgeBio Pharma - Truseltiq >> bile duct cancer (cholangiocarcinoma) that has spread or cannot be removed by surgery, who have already received a previous treatment, and whose tumor has a certain type of abnormal “FGFR2” gene.
Lantheus Holdings - Pylarify >> this is an imaging technique
ADC Therapeutics - Zynlonta >> large B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory), who have already received two or more treatments for their cancer
Mayne Pharma Group/Mithra Pharmaceuticals - Nextstellis >> Birth Control, of course it will get approved!!!
Supernus Pharmaceuticals - Qelbree >> used to treat ADHD in adults and children 6 years and older. Qelbree may increase suicidal thoughts and actions, in adults and children with ADHD, especially within the first few months of treatment or when the dose is changed. Definitely a positive here.
AVEO Oncology/EUSA Pharma - Fotivda >> to treat adults with advanced kidney cancer (advanced renal cell carcinoma or RCC) that has been treated with 2 or more prior medicines and has come back or did not respond to treatment.
Origin Biosciences/BridgeBio Pharma - Nulibry >> NULIBRY replaces the critical component your child needs to make molybdenum cofactor (MoCo) since children with MoCD Type A can't make it on their own
G1 Therapeutics - Cosela >> COSELA is a prescription medicine used to help reduce the occurrence of low blood cell counts caused by damage to bone marrow from chemotherapy.
Aurinia Pharmaceuticals -Lupkynis >> is the first FDA-approved oral treatment specifically for lupus nephritis.
Look however, how specific these medications are and how rare the majority of their indications are. Compare and Contrast that to our Leronlimab with 90 indications which are paramount amongst all of humanity. Then consider possibly, why the FDA let them slide.
Argenx - Vyvgart >> generalized myasthenia gravis (gMG)
Mirum Pharmaceuticals - Livmarli >> Indication: Treatment of cholestatic pruritis in patients with Alagille syndrome (ALGS)
Ascendis Pharma - Skytrofa >> human growth hormone indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)
Albireo Pharma - Bylvay >> treat skin itching caused by a certain inherited liver condition (progressive familial intrahepatic cholestasis-PFIC). In PFIC, a substance that your body normally makes (bilirubin) builds up in the liver and results in jaundice
Kadmon Corporation - Rezurock >> chronic graft-versus-host disease (chronic GVHD) after you have received at least 2 prior treatments (systemic therapy) and they did not work
SCYNEXIS - Brexafemme >> vaginal yeast infections
QED Therapeutics/BridgeBio Pharma - Truseltiq >> bile duct cancer (cholangiocarcinoma) that has spread or cannot be removed by surgery, who have already received a previous treatment, and whose tumor has a certain type of abnormal “FGFR2” gene.
Lantheus Holdings - Pylarify >> this is an imaging technique
ADC Therapeutics - Zynlonta >> large B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory), who have already received two or more treatments for their cancer
Mayne Pharma Group/Mithra Pharmaceuticals - Nextstellis >> Birth Control, of course it will get approved!!!
Supernus Pharmaceuticals - Qelbree >> used to treat ADHD in adults and children 6 years and older. Qelbree may increase suicidal thoughts and actions, in adults and children with ADHD, especially within the first few months of treatment or when the dose is changed. Definitely a positive here.
AVEO Oncology/EUSA Pharma - Fotivda >> to treat adults with advanced kidney cancer (advanced renal cell carcinoma or RCC) that has been treated with 2 or more prior medicines and has come back or did not respond to treatment.
Origin Biosciences/BridgeBio Pharma - Nulibry >> NULIBRY replaces the critical component your child needs to make molybdenum cofactor (MoCo) since children with MoCD Type A can't make it on their own
G1 Therapeutics - Cosela >> COSELA is a prescription medicine used to help reduce the occurrence of low blood cell counts caused by damage to bone marrow from chemotherapy.
Aurinia Pharmaceuticals -Lupkynis >> is the first FDA-approved oral treatment specifically for lupus nephritis.
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