Vowst Receives FDA Approval

Seres Therapeutics won approval from the U.S. Food and Drug Administration (FDA) on April 26, 2023, for Vowst^™ (fecal microbiota spores, live-brpk) capsules. A biotherapeutic (treatment that contains living organisms), it is indicated for preventing subsequent reinfections with Clostridioides difficile (CDI) for adults who have had antibacterial treatment for recurrent CDIs. Responsible for as many as 500,000 infections and 30,000 deaths in the U.S. each year, CDIs cause diarrhea, fever, nausea, and other symptoms, which can include inflammation of the colon. Typically, they are treated with antibiotics, which frequently result in another infection due to disruptions in the gut microbiome (microorganisms that normally inhabit the intestinal tract). Up to 65% of patients – particularly hospitalized patients, seniors, nursing home residents, and those who have immune deficiencies – have repeated CD infections. By restoring a more normal balance of microorganisms in the gut, Vowst prevents recurring CDIs for adults who have had them. Treatment with it begins at least two days but no more than four days after antibacterial therapy ends. Patients are instructed to take 296mL (10 ounces) of magnesium citrate liquid before the first dose of Vowst and not to eat or drink anything, except small amounts of water, for eight hours or longer. Patients then take four capsules each morning for three days before any food. In clinical trials, 88% of patients using Vowst remained CDI-free eight weeks after treatment. The most common side effects among clinical study patients were abdominal swelling, fatigue, constipation, chills, and diarrhea. Vowst is derived from human feces that are donated by individuals who have been screened to rule out infectious diseases. Although very slight, it still has the potential for transmitting a disease or a food allergy. Vowst should not be taken at the same time as an antibacterial drug is being used. It will be launched in collaboration withNestlé Health Science in June. Price and distribution channels are not yet known. The first biotherapeutic, Rebyota™ (fecal microbiota, live-jslm – Ferring Pharmaceuticals) suspension, received FDA approval on Nov. 30, 2022, for the same indication. As a fecal transplant, it is administered as a single dose given rectally one to three days following a course of antibiotics used to treat a recurrent CDI.

New Extended-Release Aripiprazole Approved

Abilify Asimtufii^® (aripiprazole) injection, an extended-release form of the atypical antipsychotic, was FDA approved on April 27, 2023. Injected intramuscularly (IM) once every two months by a healthcare provider, it treats adults who have schizophrenia. It also is indicated as maintenance therapy for bipolar I disorder in adults. In clinical trials, the effectiveness of Abilify Asimtufii was equivalent to that of Abilify Maintena^®, a once-monthly form of the injection. Side effects, including agitation, drowsiness, injection site pain, restlessness, and weight gain, also were similar. All antipsychotic drugs have a boxed warning that they should not be used to treat psychoses related to dementia, because they may raise the chance of death for seniors who have the condition. The new longer-acting dose form will be available in single-dose prefilled syringes containing either 720mg/2.4mL or 960mg/3.2mL of aripiprazole, with the higher dose recommended. The manufacturers, Otsuka America Pharmaceutical and Lundbeck, have not yet released their distribution, launch, or pricing plans for the drug. Its prescribing information may be found here.

Extended Pediatric Indication Approved for Trikafta

On April 26, 2023, the FDA approved Trikafta^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor – Vertex) for children between the ages of two years old and five years old who have specific subtypes of cystic fibrosis (CF). An inherited disease, CF is caused by mutations in both of the patient’s cystic fibrosis transmembrane conductance regulator (CFTR) genes, which are responsible for the proteins in ion channels on cell surfaces. Ion channels transport water and salts throughout the body. Absent or defective CFTR proteins suppress or damage ion channels, which results in thick mucus that disrupts breathing, leads to frequent infections, and interferes with digestion. Elexacaftor and tezacaftor are CFTR correctors – they help to stabilize CFTR proteins at the right places for ion channels on cell surfaces. Ivacaftor potentiates CFTR to help keep the ion channels functional, which increases the flow of water and salts into and out of cells. Trikafta is indicated for treating CF with at least one F508del mutation (the absence of protein F508) on the CFTR gene or with CFTR gene mutations that are expected to respond to Trikafta treatment based on laboratory results. Trikafta’s recommended dose depends on the child’s age and weight. It is given as oral granules that have been mixed into about 5mL (one teaspoonful) of a soft, unheated, fat-containing food, such as milk, peanut butter, or yogurt. One packet containing all three drugs is administered in the morning and one ivacaftor-only packet roughly 12 hours later. Some patients taking ivacaftor have developed cataracts, so eye examinations should be done before beginning Trikafta and periodically thereafter. The liver function also should be checked periodically for rare increases in liver enzyme levels that may be associated with taking the drugs. For revised prescribing information, go here.

Prevnar 20 Approved for Children

The FDA approved Prevnar 20^® (20-valent pneumococcal conjugate vaccine – Pfizer) as a Breakthrough Therapy on April 27, 2023, for children six weeks old and older. For preventing invasive pneumococcal disease, it is approved for all individuals who are at least six weeks old. Additionally, it is approved for children between six weeks and five years old to prevent otitis media that is caused by any of the seven subtypes of pneumonia included in it. Prevnar 20 is administered by IM injections at two, four, and six months of age followed by a fourth dose at 12 months to 15 months. Adults need only one shot. The Advisory Committee on Immunization Practices (ACIP) of the Center for Disease Control and Prevention (CDC) is expected to include Prevnar 20 in the pediatric immunization schedule when they meet in late June. Here is the complete prescribing information for Prevnar 20.

Additional Indication for Sculptra

Galderma announced on April 26, 2023, that its Sculptra^® (injectable poly-L-lactic acid [PLLA-SCA]) has received a new FDA indication to diminish fine lines and wrinkles in the cheeks. Unlike some other products, Sculptra is not a dermal filler. Instead, it encourages natural collagen production to enhance skin firmness and smoothness gradually. It has previous approvals to decrease chin wrinkles and nasolabial folds (lines between the nose and mouth) for patients whose immune systems are intact. It also can be used to improve signs of facial lipoatrophy (fat loss) for individuals who have HIV. In clinical trials for restoring cheek firmness, it was administered in up to four sessions of multiple injections into the deep layers of the skin once every three to four weeks. Two years after the last session, 94% of patients still showed improvement. Some patients experience generally mild-to-moderate side effects such as bruising, hypersensitivity, itching, nodules, or swelling at the injection sites, which typically lasts for only a few days. More serious side effects, including hypersensitivity reactions and infections, are possible. Sculptra is distributed to health providers, primarily cosmetic surgeons and dermatologists, who have training and experience with its use. Look here for detailed provider instructions for its use and here for a patient information sheet.

MedWatch Update

Akorn Pharmaceutical Products After filing for bankruptcy in February, Akorn Operating Company completely ceased operations on April 26, 2023. Patients who have Akorn products are advised to contact their doctors or pharmacies to get prescriptions for substitutes from other manufacturers. Once the new drugs are available, the Akorn products should be thrown out. More information, including a list of affected products, is in the FDA’s notice.