Update for the Week Ending March 7, 2020

Regulatory Update
 
The FDA approved isatuximab (Sarclisa, Sanofi) on 3/2/2020 to be given in combination with pomalidomide (Revlimid, Celgene) and dexamethasone for the treatment of multiple myeloma in patients that received two or more prior therapies including lenalidomide and a proteasome inhibitor. Sanofi set WAC for a 5 ml vial of isatuximab at $650 and $3,250 for a 25 ml vial.
 
The FDA approved osilodrostat (Isturisa, Novartis) on 3/6/2020 for the treatment of adults with Cushing's disease who either are candidates for pituitary gland surgery or in whom the disease persists after surgery.
 
Redhill launched amoxicillin, omeprazole, rifabutin (Talicia) on 3/9/2020 at a WAC of $650 for 168 capsules. Omeprazole, amoxicillin and rifabutin was approved on 11/5/2019 for the treatment of Helicobacter pylori infection in adults.
 
The FDA accepted the NDA for Urovant/Kyorin/Merck’s vibegron for the treatment of overactive bladder and set a PDUFA date of December 26, 2020.
 
The FDA accepted the resubmitted NDA for Trevena’s oliceridine as a treatment for moderate-to-severe acute pain and set a PDUFA date of 8/7/2020.
 
The FDA accepted the BLA for Pfizer’s tanezumab, in March 2020, for the treatment of chronic osteoarthritis pain in patients who have experienced inadequate pain relief with other analgesics and set a PDUFA date in December 2020.
 
The FDA granted a Rare Pediatric Disease designation to Stealth BioTherapeutics’ elamipretide for the treatment of Barth syndrome.
 
Mallinckrodt initiated a rolling submission NDA for terlipressin for the treatment of patients with hepatorenal syndrome type 1 in March 2020.
 
Janssen submitted an MAA for ponesimod for treatment of adults with relapsing-remitting multiple sclerosis.
 
Announced Research Updates
 
AstraZeneca announced that in the 1,126 patient, Phase III, open-label, DANUBE trial, neither durvalumab plus tremelimumab nor durvalumab monotherapy improved overall survival compared to standard-of-care chemotherapy in patients with unresectable stage IV bladder cancer. 
 
Published Research Updates
 
In a 279 patient trial, there was no difference in mortality in patients treated with levosimendan compared to intra-aortic balloon counterpulsation in patients with poor left ventricular function undergoing coronary artery bypass grafting (CABG) with ejection fraction less than 35%.
 
In a 65 patient, 4-day, Phase II, open-label trial, treatment with terlipressin reduced portal venous pressure by 1.5 mmHg in patients with portal vein pressure >12 mmHg after hepatectomy.
 
In the 48-week, 616 patient, Phase III ATLAS Trial, 1.6% of patients that received a monthly IM injection of cabotegravir and rilpivirine had an HIV-1 RNA of 50 copies/mL or > compared to 1% of patients that continued a standard daily thee drug oral regimen in patients with plasma HIV-1 RNA levels of less than 50 copies per milliliter for at least 6 months while taking standard oral antiretroviral therapy. In the 48-week, 566 patient, Phase III FLAIR trial, patients were treated with 20 weeks of daily oral induction therapy with dolutegravir-abacavir-lamivudine, then randomized to monthly IM injection of cabotegravir and rilpivirine or continuation of dolutegravir-abacavir-lamivudin. After 48 weeks 2.1% of patients that received cabotegravir/rilpivirine monthly had an HIV-1 RNA of 50 copies/mL or > compared to 2.5% of patients that continued dolutegravir-abacavir-lamivudin in patients with with HIV-1 infection who had not previously received antiretroviral therapy.