Interchangeability Approved for Rezvoglar
On Nov. 16, 2022, the U.S. Food and Drug Administration (FDA) approved Rezvoglar™ (insulin glargine-aglr – Eli Lilly & Company) as interchangeable with Lantus (insulin glargine – Sanofi). First approved as a biosimilar to Lantus on Dec. 17, 2021, Rezvoglar could not be approved as automatically switchable in states where substitution is allowed until a one-year exclusivity period expired for the first substitutable biosimilar, Semglee® (insulin glargine-yfgn), and an unbranded insulin glargine product, which both are manufactured by Viartis/Biocon Biologics. Rezvoglar is available in packages of five prefilled 3mL (100U/mL) KwikPens®. Insulin glargine is a long-acting (basal) form of the drug, which is indicated for maintaining blood sugar control for patients who have type 2 diabetes. In combination with shorter-acting insulin, it treats type 1 diabetes, as well. Administered subcutaneously (SC) at about the same time every day, doses vary according to the patient’s blood sugar readings, exercise amounts, meal timing, and overall health. Injections should be given into the abdomen, thigh, or upper arm, with locations, changed frequently to limit the chances that abnormalities will occur in the fats or proteins under the skin at injection sites. Insulin pens should not be shared among patients. Here is the current prescribing information for Rezvoglar.
Liletta Use Extended to Eight Years
Liletta® (levonorgestrel-releasing intrauterine system – Medicines360) 52mg now can remain in use longer for contraception. The duration of its effectiveness was extended by the FDA on Nov. 10, 2022. Although it can be removed at any time that the patient decides, its expanded approval means that Liletta can be used continuously as contraception for as long as eight years before it must be removed. The clinical trial that supported longer use included a diverse group of patients. Across all groups, Liletta stayed more than 99% effective for the entire eight-year duration. Inserted and removed by a medical professional, it does not provide emergency contraception and it does not prevent sexually transmitted diseases (STDs). Women who are pregnant, who are prone to pelvic or genital infections, who have acute liver disease, or who have cancers that could be worsened by progestin should not use Liletta. In August 2022, another progesterone-only IUD, Mirena® (Bayer), also was FDA approved for continuous contraceptive use for up to eight years. Check here for Liletta’s current prescribing information.
Indications Limited for Zejula
Zejula® (niraparib – GSK) capsules were awarded their first FDA approval in 2017 for the second-line maintenance treatment of women who have a recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer that has responded to treatment with platinum-based chemotherapy (chemo). Later, it was approved for the same three gynecological cancers that tested positive for a homologous recombination deficiency (HRD) proven by either a deleterious or suspected deleterious germline BRCA mutation or genomic instability and that had worsened more than six months following the last of at least three rounds of chemo. A third indication, as first-line, monotherapy maintenance for women who have advanced cases of one of the cancers it targets and who have had a complete or partial response to first-line chemo, regardless of biomarker status, was granted in 2020. However, based on results from a continuing clinical study that show no advantages for some patients taking Zejula over patients taking a placebo, the indications have been narrowed, significantly. In September, GSK withdrew the indication for late-line HRD+ cancer treatment. On Nov. 11, the first indication also was withdrawn. Now, it is approved only for initial use after a response to platinum-based chemo, but only for patients proven to have germline BRCA mutations. No new patients will be prescribed Zejula for second or later-line maintenance therapy and those already using it for the withdrawn indications will be evaluated for alternate treatment options. Zejula is a poly ADP-ribose polymerase (PARP) inhibitor that destroys cancer cells or curtails their growth by interfering with an enzyme that cancer cells need to repair damage caused by drug treatment. Its revised prescribing information will be posted here.