Exblifep Approved

Exblifep^® (cefepime/enmetazobactam) is a new injectable antibiotic that was approved by the U.S. Food and Drug Administration (FDA) on Feb. 22, 2024. It contains a well-established cephalosporin antibiotic and a new beta-lactamase inhibitor to treat adults who have complicated urinary tract infections that result from specific bacteria. It will be infused intravenously (IV) once every eight hours for at least seven days and up to 14 days. Approved as a Qualified Infectious Disease Product (QIDP), Exblifep offers an alternative option for patients who have potentially fatal infections. Developed by Orchid Pharmaceuticals, Exblifep will be distributed by Allecra Therapeutics beginning in the second or third quarter of 2024. No information is available about its cost. Here is the full prescribing information.

New Xolair Indication

A monoclonal antibody that reduces inflammation by blocking the effects of immunoglobulin E (IgE), Xolair^® (omalizumab – Genentech/Novartis Pharmaceuticals) injection, received a new indication from the FDA on Feb. 16, 2024. It is the first drug indicated to decrease the risk of severe allergic reactions, including anaphylaxis, for patients as young as one year old who have one or more IgE-related allergies to foods. Dosing, which depends on the patient’s weight and IgE blood levels before treatment begins, ranges from 75mg to 600mg administered subcutaneously (SC) once every two weeks or four weeks. In clinical trials, individuals who have allergies to different foods were able to consume small amounts of the food with no allergic reaction after 16 to 20 weeks of treatment. For example, 68% of those who have peanut allergies could eat the equivalent of two and one-half peanuts with no serious reactions as compared to 5% of the participants who used a placebo injection. People using Xolair to reduce the chance of allergic reactions still need to be careful to avoid the allergen since Xolair is not intended for emergency recovery from an allergic attack. Individuals still should have epinephrine injectors at hand. Food Allergy Research and Education (FARE) estimates that about 5.6 million children and 27.4 million adults have food allergies, with high percentages of them due to IgE. Xolair originally was approved by the FDA in 2003 for individuals 12 years and older who have moderate to severe persistent allergic asthma, which later was extended to include children as young as six years old. It also has indications after other treatments have failed for treating patients 12 years of age and older who have chronic spontaneous urticaria and for patients aged 18 years and older who have chronic rhinosinusitis with nasal polyps. Because Xolair itself may cause anaphylaxis, it has a boxed warning. At least the first few doses of it should be given by a healthcare provider in a facility staffed and equipped to manage emergencies. Patients or their caregivers may be trained to administer the injections at home if Xolair is well tolerated. It is available in auto-injectors, prefilled syringes, and single-dose vials. Check here for its complete revised prescribing information.

Expanded Indication for Tagrisso

Under its Priority Review program, the FDA expanded the non-small cell lung cancer (NSCLC) indication for AstraZeneca’s Tagrisso^® (osimertinib) tablets on Feb. 16, 2024. It now can be used, along with chemotherapy (chemo) that contains pemetrexed and a platinum-based drug, as initial treatment for adults who have advanced or metastatic NSCLC that has epidermal growth factor receptor (EGFR) mutations. A third-generation, irreversible EGFR-tyrosine kinase inhibitor (TKI), Tagrisso also has FDA-approved indications as monotherapy for first-line, adjuvant (secondary), and later-line therapies to treat adults who have NSCLC that tests positive for specific EGFR mutations. The American Lung Association (ALA) estimates that NSCLC affects about 80% of approximately 605,000 individuals who are living with lung cancer in the United States. Up to 15% of patients who have NSCLC also are believed to have EGFR mutations. Recommended dosing is 80mg once daily until the cancer worsens or the drug’s side effects are no longer bearable. In the FLAURA2 clinical study, progression-free survival (PFS) for patients treated with Tagrisso and chemo averaged 25.5 months versus 19.9 months for patients who took only Tagrisso. Updated prescribing information is here.

New Maintenance Dosing Schedule for Tecvayli

On Feb. 20, 2024, the FDA approved Tecvayli^® (teclistamab-cqyv – Eli Lilly and Company) for use once every two weeks. Originally, it was granted the FDA’s Accelerated Approval in October 2022 as the first bispecific B-cell maturation antigen (BCMA) antibody and a cluster of differentiation 3 (CD3) T-cell engager. It is indicated for the treatment of adults who have multiple myeloma that has returned or become resistant despite four or more specific previous therapies. Given by SC injections, the recommended “step-up” dosing for Tecvayli is 0.06mg/kg on the first day, 0.3mg/kg on the fourth day, and 1.5mg/kg on the seventh day. Then, maintenance is scheduled at 1.5mg/kg once per week. Now, patients who have had a complete response for at least six months on the once-weekly schedule may be eligible to switch to 1.5mg/kg once every two weeks. Tecvayli has a boxed warning and it is available only through a risk evaluation and mitigation strategy (REMS) because using it may be associated with potentially fatal side effects, such as cytokine release syndrome (CRS) and nerve damage. Here is its revised prescribing information.

First Generic for Rectiv

Cosette Pharmaceuticals received approval from the FDA on Feb. 16, 2024, for nitroglycerine ointment, 0.4%. The first generic for AbbVie’s Rectiv (nitroglycerine) Ointment, 0.4%, is applied to the anus to treat the pain of chronic anal fissures. Directions are to use one inch of the ointment once every 12 hours for as long as three weeks at a time. It should not be used on any other part of the body. Patients who have anemia or elevated intracranial pressure should not use it. Nitroglycerine should be avoided while the patient is taking a phosphodiesterase 5 (PDE5) inhibitor, such as sildenafil, because the combination may lower blood pressure too much. Using nitroglycerine also may be associated with severe headaches. The generic already is being shipped in the U.S., but the price is not yet known. At Good Rx, a 30-gram tube of Rectiv retails for about $650. Cosette has 180 days of exclusivity before other generics can be introduced. Rectiv had U.S. sales of $21.2 million for the 12 months that ended on Jan. 31, 2024, according to information from IQVIA.

Tegsedi Being Discontinued As a result of low sales, Akcea Pharmaceuticals, now a subsidiary of Ionis Pharmaceuticals, has informed prescribers that it will stop marketing Tedsegi^® (inotersen) injection in the United States on Sept. 27, 2024. No issues with the effectiveness of the drug or its safety were involved in the decision. The antisense oligonucleotide was FDA-approved in 2018 to treat adults who have polyneuropathy (widespread peripheral nerve damage) caused by hereditary transthyretin-mediated amyloidosis (hATTR). Only a few thousand Americans are believed to have polyneuropathy related to hATTR, which involves bent and folded proteins produced by mutated RNA. The resulting amyloid fibrils (unusable proteins) deposit in nerves, where they produce pain in the arms, feet, hands, and legs. Because they also accumulate in organ tissue, the fibrils can enlarge the heart and damage other organs. To treat polyneuropathy of hATTR, Tedsegi is given once a week as an SC injection. Akcea is advising healthcare providers not to start new patients on Tegsedi and to move those already using it to another drug before the withdrawal date. Other agents with indications similar to Tegsedi’s are Onpattro^® (patisiran – Alnylam Pharmaceuticals), which is given once every three weeks by IV infusion; Wainua^™ (eplontersen – AstraZeneca/Ionis Pharmaceuticals), given once a month by SC injection; and Amvuttra^™ (vutrisiran – Alnylam), given once every three months by SC injection. Similar to Tegsedi, they all interfere with the RNA that carries damaged sequences for hATTR amyloidosis – decreasing or preventing the formation of amyloid fibrils. Laboratory testing support for patients using Tedsegi will continue until Nov. 27, 2024. Patients who need more information should contact the physician who prescribed Tegsedi.