Airsupra Receives FDA Approval

AstraZeneca and its development partner, Avillion, gained approval from the U.S. Food and Drug Administration (FDA) on Jan. 10, 2023, for Airsupra™ (albuterol 90mcg/budesonide 80mcg) multi-dose inhaler (MDI). A new combination containing a short-acting beta2-agonist (SABA) to relieve acute asthma symptoms and an inhaled corticosteroid (ICS) to manage inflammation, it treats asthma in adults. According to the Centers for Disease Control and Prevention (CDC), more than 21 million Americans who are at least 18 years old have asthma. Although both drugs have been available as inhaled forms for decades, either alone or in combination with other asthma medications, Airsupra is the first to contain both a SABA and an ICS and the first to classify an ICS as a rescue medication rather than a controller. Specifically, it is indicated to be used on-demand to prevent or treat bronchoconstriction and to decrease the probability of acute asthma exacerbations (acute episodes). The recommended dose is two inhalations when needed to relieve the symptoms of an asthma attack. No more than 12 sprays should be used within any 24-hour period and the inhaler should be shaken before each inhalation. To prime the device and to assure that the correct amount of the drugs are delivered, four sprays should be released into the air where they cannot be inhaled before the first dose from each new inhaler. If the device has been cleaned or dropped or if it has not been used for one week or longer, two priming sprays should be released into the air before a dose is inhaled. In phase III clinical trials, patients using Airsupra had fewer severe asthma episodes and they needed lower doses of systemic corticosteroids to control exacerbations as compared to patients using only inhaled albuterol. Additionally, the chance of having an episode was reduced by 27% for combination therapy. Adverse reactions, which included coughing, headaches, and nose/throat infections, generally were mild and similar for both treatment groups. Wholesale acquisition cost (WAC) has not yet been announced and launch is not expected until early in 2024. Look here for prescribing information.

Label Extension for Adacel

The indications for Adacel (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed [Tdap] – Sanofi-Pasteur) were expanded by the FDA on Jan. 9, 2023. It now can be given to women who are in the last three months of pregnancy to help keep their babies from getting pertussis (whooping cough) before two months of age. Before then, infants’ immune systems have not developed enough for them to begin receiving the five-dose vaccination schedule of a different combination, diphtheria/tetanus toxoids/acellular pertussis (DTaP), which is recommended for all children. In the United Kingdom (UK), where Adacel has been approved as a maternal immunization to protect newborns since 2012, the chance of having pertussis was reduced by 90%, and the chance of a baby’s death from it was reduced by 95% among babies whose mothers were vaccinated in the last trimester of pregnancy. Previously, Adacel was approved in the U.S. only as booster doses at least five years following the last dose of DTaP or eight years following the latest dose of Tdap for individuals between the ages of 10 years and 64 years old. The FDA approved another combination Tdap booster vaccine, GlaxoSmithKline Biologicals’ Boostrix (tetanus toxoid/reduced diphtheria toxoid/acellular pertussis vaccine, adsorbed [Tdap]) injection, for the same indication in October 2022. Adacel’s revised prescribing information is here.

Rybelsus Approved for First-Line Use

The FDA granted approval for Rybelsus^® (semaglutide – Novo Nordisk) tablets on Jan. 12, 2023, as initial treatment for adults who have type 2 diabetes. When nonpharmacologic interventions, such as diet modifications and increased exercise, have failed to control blood sugar, Rybelsus now may be used before any other drug treatments are tried. First FDA approved in September 2019 for second-line or later therapy, Rybelsus is the only oral glucagon-like peptide-1 (GLP-1) receptor agonist available in the U.S. Drugs in the class affect blood glucose levels through several pathways, which include slowing glucose absorption following meals, decreasing glucagon production and promoting insulin secretion from the pancreas. The recommended starting dose for Rybelsus is 3mg/day taken at least 30 minutes before the first food, beverage, or other oral medications of the day and with no more than four ounces of plain water. After 30 days, the dose can be increased to 7mg once daily, if needed. For blood sugar that is still high after 30 more days, the maximum recommended dose is 14mg/day. All GLP-1 agonists have a boxed warning that tumors of the thyroid gland (thyroid C-cell tumors) have occurred among laboratory animals treated with some of the drugs during preclinical studies. Whether or not they cause humans to develop thyroid C-cell tumors is not known. Patients who have medullary thyroid carcinoma (MTC), individuals with close family members who have thyroid C-cell tumors, and those who have Multiple Endocrine Neoplasia syndrome type 2 (tumors in more than one gland) should not use Rybelsus. It is not approved to treat type 1 diabetes. Updated prescribing information can be found here.

Generic Launched for Trokendi XR

Topiramate extended-release capsules, a generic for Trokendi XR^® (Supernus Pharmaceuticals) 25mg, 50mg, and 100mg strengths, have been introduced to the U.S. market. Zydus Lifesciences announced the launch on Jan. 6, 2023. Used for epilepsy, extended-release topiramate is indicated to be used alone to treat partial-onset seizures or generalized tonic-clonic seizures for patients who are at least six years old and who have not been treated for seizures previously. In combination with other antiepileptic drugs, it is approved for the same types of seizures and also for seizures resulting from Lennox-Gastaut syndrome in the same age group. An additional indication is for the prevention of migraine headaches for patients who are 12 years old and older. Pricing for the generic capsules is not available. Trokendi XR’s 200mg strength capsules remain brand only. According to IQVIA, U.S. sales of Trokendi XR amounted to $488 million for the 12 months that ended on Nov. 30, 2022.

Cambia Generic Available

Camber Pharmaceuticals has released a diclofenac potassium oral solution, a generic for Depomed’s Cambia®. The non-steroidal anti-inflammatory drug (NSAID) is indicated for treating adults who have acute migraines. Diclofenac potassium solution does not prevent migraines and it is not approved to treat cluster headaches. All NSAIDS have boxed warnings that using them may be associated with cardiovascular (CV) events, such as heart attacks or strokes, and that they may increase the possibility of serious gastrointestinal (GI) side effects, such as bleeding and ulcers. The generic will be dispensed in boxes of nine individually wrapped 50mg pouches with directions to mix one packet with 30mL to 60mL (about two to four tablespoons) of water and drink it right away. No directions are given for the timing of subsequent doses, but patients are advised to use the lowest effective dose for the shortest timeframes that alleviate the migraine. The oral solution cannot be substituted with any other dosage form of diclofenac. In the U.S., annual sales of Cambia were about $42 million.

Market Withdrawal for Lumoxiti

In the United States, AstraZeneca’s immunotoxin, Lumoxiti^™ (moxetumomab pasudotox-tdfk) injection will be completely withdrawn from the market by the end of August 2023. A CD22-directed antibody-toxin conjugate, it originally was FDA approved in September 2018 to treat adults who have recurrent or resistant hairy cell leukemia (HCL) despite at least two rounds of previous therapy. A slowly progressing form of B-cell cancer, HCL is diagnosed to fewer than 1,500 new patients in the U.S. per year. Although Lumoxiti has some potentially severe side effects, the decision to remove it from the sale was based only on business reasons, not on any effectiveness or safety concerns. Since it is given as no more than six 28-day cycles, any patients currently using Lumoxiti will have time to complete therapy. Oncologists should not start new patients on it, however. For more information, please see AstraZeneca’s letter to prescribers.