Additional Approval for Keytruda

On Jan. 12, 2024, the U.S. Food and Drug Administration (FDA) granted a new approval for Merck’s Keytruda^® (pembrolizumab) injection. Used along with chemotherapy (chemo) and radiation, the programmed death receptor-1 (PD-1)-blocking antibody now is indicated to treat patients who have stages III to IVA cervical cancer. In the decisive Keynote-A18 clinical trial, using Keytruda and chemoradiation decreased the chances of worsening cancer or death by 42% for patients who have stage III to IVA cancers. The combination treatment was not as successful, though, for patients who have earlier stages of the disease. Previously, Keytruda has been FDA-approved to be used by itself to treat patients whose PD-L1 positive cervical cancers have returned or resisted treatment after chemo. In addition, it also is indicated alone or in combination with other cancer drugs to treat some kidney, esophageal, stomach, and head and neck cancers; several non-small cell lung cancers (NSCLC); Merkel cell carcinoma; multiple myeloma and non-Hodgkin lymphoma. It also has approvals for pediatric and adult patients whose cancers have specific genetic characteristics (biomarkers), rather than developing from a particular body tissue. For the majority of its indications, including the newest one, Keytruda is administered as a 30-minute IV infusion at 200mg once every three weeks or 400mg once every six weeks. Revised prescribing information may be found here.

New Indication for HyQvia

The FDA approved a second indication for Takeda’s HyQvia^® (immune globulin infusion 10% [human] with recombinant human hyaluronidase) on Jan. 12, 2024. An immune globulin (IG) derived from human blood plasma, it first was approved by the FDA in 2014 to restore at least partial immune function for adults who have a primary immunodeficiency (PI) — a genetic disorder of the immune system. Later it was approved to treat PIs for patients at least two years old. HyQvia’s new indication is as maintenance therapy to prevent a decline of neuromuscular function for adults who have chronic inflammatory demyelinating polyneuropathy (CIDP). Believed to affect up to 40,000 patients in the U.S., CIDP is difficult to diagnose because its symptoms are vague and inconsistent. Caused by inflammation of the nerves, it results in pain, tingling, and weakness — especially in the arms and legs. A mainstay of treatment is intravenous doses of immunoglobulin (IVIG). Once symptoms of CIDP have been stabilized on a set dose of an IVIG, patients can be switched to the same dose of HyQvia administered by subcutaneous (SC) infusion once every two to four weeks. Patients or their caregivers may be able to give the injections in a home setting. A boxed warning cautions that using any immune globulin may be associated with blood clots, so blood viscosity should be checked for patients who have risk factors for blood clots. Here is the prescribing information for HyQvia.

Labeling Addition for Dupixent

Dupixent^® (dupilumab – Regeneron Pharmaceuticals/Sanofi) injection was FDA-approved on Jan. 12, 2024, to include additional clinical study results in its prescribing information. Results from the phase III LIBERTY-AD-HAFT trial, which enrolled about 230 patients who were at least 12 years old and who had persistent moderate-to-severe atopic dermatitis (AD) of the hands and feet, now are part of the labeling. In the trial, AD on the hands and feet resolved completely or mostly for 40% of patients treated with Dupixent after four months and 52% of them had significantly less itching. Comparatively, 17% of those using a placebo had clear or almost clear skin and 14% experienced a decrease in itching. Dosing was once every two weeks at 300mg for adults and 200mg or 300mg, depending on their weight, for patients under the age of 18 years old. Dupixent is an interleukin-4 alpha-receptor (IL-4Rα) blocking antibody that disrupts the inflammatory process. Available in single-dose prefilled syringes and pen devices, it is administered subcutaneously (SC) either at home by patients or caregivers, or in a healthcare setting by a professional. In addition to the treatment of adults who have prurigo nodularis or chronic rhinosinusitis with nasal polyposis, Dupixent is approved by the FDA to treat patients aged 12 years and older for eosinophilic esophagitis and patients aged six months and older for atopic dermatitis. It also is indicated as maintenance therapy for patients six years old and older who have asthma with an eosinophilic phenotype. Click here for revised prescribing information

Generic launched for Indocin Oral Suspension

After its approval on Jan. 12, 2024, indomethacin oral suspension was released on the U.S. market. ANI Pharmaceuticals’ generic for Indocin^® Oral Suspension (Zyla Life Sciences), it was approved with the FDA’s Competitive Generic Therapy (CGT) designation, which gives the manufacturer, ANI Pharmaceuticals 180 days of exclusivity. The non-steroidal anti-inflammatory drug (NSAID) is indicated to treat inflammatory conditions that include rheumatoid arthritis (RA), osteoarthritis, and ankylosing spondylitis. Recommended daily doses vary from 100mg (20mL) to 150mg (30mL) per day in two or three divisions according to the condition being treated. The lowest effective dose should be used for the shortest amount of time that manage the patient’s pain. Boxed warnings on all NSAIDs, including indomethacin, explain that they may increase the risk of having blood clots, heart attacks, and strokes, as well as raise the chance of gastrointestinal (GI) side effects, such as ulcers. IQVIA estimates the annual U.S. sales of Indocin Oral Suspension at $4.1 million.

Expiration Date Extended for Narcan Emergent BioSolutions gained FDA approval on Jan. 17, 2024, to expand the effective period for its Narcan (naloxone) 4mg/0.1mL nasal spray from three years to four years. Granted over-the-counter (OTC) status in March 2023, Narcan is indicated for emergency use to resuscitate patients who are in respiratory failure after an acute opioid overdose. By blocking opioid receptors, it displaces the opioid drug and decreases the negative effects of a drug overdose. One dose (one spray) should be given as soon as an overdose is observed or suspected. Immediately after giving the drug, emergency medical help should be requested. If needed, one additional dose (in alternating nostrils) can be given every two to three minutes until professional assistance arrives. Few side effects are associated with the use of Narcan, but some patients may experience temporary constipation, headache, and/or nausea. It is not effective for overdoses of non-opioids, such as methamphetamine; but it is not harmful if administered accidentally to a person who has not overdosed – someone who is unconscious as a result of very low blood sugar, for example. Narcan that already is on the market should not be used past the expiration date on the label. For full directions about its use, look at the company’s website found here.