New Oral Formulation of Radicava Approved

U.S. Food and Drug Administration (FDA) approved Mitsubishi Tanabe Pharma America’s Radicava ORS® (edaravone) oral suspension for treating adults with amyotrophic lateral sclerosis (ALS), also commonly known as Lou Gehrig’s disease. In the United States, about 16,000 individuals have ALS, a progressive disease that destroys nerve cells in the brain and spinal cord (central nervous system or CNS). Patients who have it gradually lose the abilities to move, speak, swallow and even breathe. With most patients diagnosed between the ages of 40 years and 70 years, life expectancy is only three years to five years after ALS diagnosis. Radicava, an intravenous infusion for treating ALS, was first approved in 2017. The recommended Radicava ORS dose is 105mg (5mL) taken orally or by a feeding tube in the morning after overnight fasting, and food should not be consumed for an hour after dosing. Similar to intravenous (IV) Radicava, the initial 28-day dosing cycle consists of daily oral doses for the first 14 days, then not at all for the next 14 days. Subsequent cycles will include dosing of Radicava ORS for 10 out of the first 14 days, then 14 days without treatment. Radicava ORS will be available as a starter kit containing enough medication for 14 days of therapy. It will also be available in 50mL bottles (105mg/5mL). Launch date and pricing information are not known at this time.

Generic to Esbriet Launched

On May 12, 2022, Sandoz announced the launch of its AB-rated generic to Genentech’s Esbriet® (pirfenidone), an oral medication used to treat idiopathic pulmonary fibrosis (IPF). The generic is supplied as 267mg and 801mg tablets; branded Esbriet is also supplied as 267mg capsules. IPF is a fatal disease in which progressive lung scarring limits the ability of the lungs to absorb oxygen, making it difficult to breathe. There are approximately 140,000 Americans with IPF. Since patent litigation between Sandoz and Genentech is ongoing, the launch of Sandoz’s generic is considered “at risk”. According to IQVIA, 2021 U.S. sales for Esbriet were $867 million.

Generics Released for Velcade

Several companies, including Apotex, Aurobindo Pharma, Baxter and Fresenius Kabi, have launched bortezomib injection 3.5mg, a therapeutically equivalent generic to Takeda’s Velcade®. Bortezomib is a proteasome inhibitor for treating adult patients who have multiple myeloma or mantle cell lymphoma (MCL). It is administered as either an IV bolus or a subcutaneous (SC) injection at a dose of 1.3mg/m2. For multiple myeloma, doses are given once a week or twice a week in nine six-week-long cycles. To treat MCL, dosing is twice a week in six three-week cycles. In December 2019, Dr. Reddy’s Laboratories introduced an IV-only form of bortezomib that was FDA approved as a new drug, not a generic. IQVIA estimated that U.S. sales of Velcade for the 12-month period that ended on March 31, 2022, amounted to approximately $1.2 billion.

COVID-19 Indication Approved for Olumiant

Olumiant® (baricitinib) tablets, a Janus-Associated kinase (JAK) inhibitor made by Eli Lilly and Company, was approved by the FDA for a COVID-19 indication on May 10, 2022. It now is approved as monotherapy for adult patients who are hospitalized due to COVID-19 and who need breathing support from oxygen supplementation, mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Often called a heart-lung machine, ECMO is used in critical situations to pump blood outside of the body through filters that remove carbon dioxide and devices that replenish oxygen and then return it to the patient. The recommended dose of Olumiant for the new indication is 4mg once a day for two weeks or until the patient leaves the hospital. The FDA initially authorized Olumiant in November 2020, for use with Veklury® (remdesivir) injection, to treat the same patient group. The original Emergency Use Authorization (EUA) was amended in 2021, to authorize Olumiant as monotherapy and to include patients as young as two years old who need any of the three types of breathing support while hospitalized for COVID-19. The EUA for pediatric patients remains in effect. A boxed warning outlines the increased risks of blood clots, cancer and serious infections that may be associated with the use of Olumiant. Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Olumiant originally was fully FDA approved in June 2018, for second-line treatment of rheumatoid arthritis (RA). Look for updated Fact Sheets here for prescribers and here for patients and caregivers.

Temporary Hold for Lutathera and Pluvicto

After potential quality-control problems were identified in some of its manufacturing facilities, Novartis has halted the production for two radioactive therapies until the issues are corrected. Lutathera® (lutetium Lu 177 dotatate) injection is indicated to treat adults who have gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) injection treats some prostate cancers. Each includes a targeting agent specific to the type of cancer cells and a radioactive isotope that damages the cancer’s DNA. Limited amounts of Lutathera will be supplied in Asia and Europe from an unaffected facility, but neither drug will be available in North America for several weeks or longer. Novartis hopes to resume at least some production of both drugs at the affected facilities within the next six weeks.