Feb. 18, 2022

Emergency Use Authorization for Bebtelovimab to Treat COVID-19

The U.S. Food and Drug Administration (FDA) has granted a new monoclonal antibody, bebtelovimab, Emergency Use Authorization (EUA) for the treating certain non-hospitalized patients (12 years of age and older who weigh at least 40kg) who have mild-to-moderate COVID-19, confirmed by a COVID-19 test, and who are at high risk for progression to severe disease when no alternative treatment options are accessible or appropriate. Lilly received EUA on Feb. 11, 2022, after data showed the monoclonal antibody was fully effective at neutralizing the Omicron variant, the dominant variant in the U.S., as well as all other circulating variants. It is administered by intravenous (IV) injection at a dose of 175mg given over at least 30 seconds. The U.S. government has purchased 600,000 doses from Lilly for $720 million. Since the situations in different areas as well as in individual healthcare settings can vary greatly and change rapidly, the FDA has posted links to current information on COVID-19, its treatments, vaccines and other facts on their EUA page.

Dhivy Launched

Dhivy™ (Avion Pharmaceuticals) tablets is a new formulation of carbidopa/levodopa that was approved by the FDA in November 2021, but not released until early February 2022. It is indicated to treat Parkinson’s disease, parkinsonism after encephalitis and symptomatic parkinsonism that results from poisoning by carbon monoxide or manganese. Although multiple carbidopa/levodopa products, including generics, are available in the U.S. Dhivy is the only one that is scored to break into four equal sections — each containing 6.25mg of carbidopa and 25mg of levodopa – to make dosage adjustments easier. The recommended initial dose is one whole tablet (25mg carbidopa/100mg levodopa) taken three times a day. If needed, doses can be raised by as much as one whole tablet every day or every other day until the lowest effective dose, containing at least 70mg of carbidopa, is reached. The maximum daily dose is eight tablets (totaling 200mg of carbidopa and 800mg of levodopa). Patients taking any carbidopa/levodopa product may have sudden episodes of sleepiness, impaired impulse control, hallucinations, abnormal movements or depression. Taking one of the drugs may aggravate peptic ulcer disease and glaucoma, as well. Abrupt discontinuation may result in high fevers and/or confusion.

Expanded Indication for Solosec

Lupin’s Solosec® (secnidazole) granules, a single-dose, oral antimicrobial, was FDA approved for use by patients as young as 12 years old on Jan. 26, 2022. Originally approved in 2017 to treat adults who have vaginal infections caused by specific kinds of bacteria, it also is indicated to treat trichomoniasis, a sexually-transmitted infection (STI) caused by a parasite. Its recommended dosing is one packet, containing 2Gm of Solosec, sprinkled onto a soft food, such as yogurt, and consumed within one-half hour. It may be taken alone or during a meal, but it should not be mixed into a liquid. For trichomoniasis, both the infected individual and any sexual partners should be treated at the same time.

Pyrukynd® (mitapivat)

At a Glance

• Brand (Generic) Name: Pyrukynd (mitapivat)
• Manufacturer: Agios Pharmaceuticals
• Date Approved: Feb. 17, 2022
• Indication: To treat hemolytic anemia for adults who have PK deficiency
• Dosage Forms Available: 5mg. 20mg and 50mg tablets
• Launch Date: Within two weeks
• Estimated Annual Cost: $334,880
• In Western countries, between three and nine individuals per million are diagnosed with a PK deficiency.
• For patients who have PK deficiency, mutations in the PKLR gene cause weak, short-lived RBCs. The subsequent chronic hemolytic anemia leads to constant fatigue. Patients also may experience jaundice and/or an enlarged spleen if increased amounts of dead RBCs can’t be filtered out of the body fast enough. Many patients have trouble concentrating; and some develop severe osteoporosis, pulmonary hypertension and/or recurring gallstones.
• Currently, treatment for PK deficiency consists of supportive measures that may include RBC transfusions and supplements of folic acid to help control anemia. Some patients need chelation therapy that removes excess iron after transfusions. To help strengthen bones, many patients take vitamin D and calcium. The removal of their spleens is necessary for some patients, and some need gallbladder removal due to an increased tendency to produce gallstones. A few patients have been cured through donated stem cell transplants.
• Mitapivat stimulates production of the missing PK enzyme to treat the cause of PK deficiency.
• In one phase III clinical trial, hemoglobin levels increased for 16 of the 40 patients taking Pyrukynd compared to none of the patients taking a placebo. Actively treated participants also saw decreases in fatigue and jaundice.
• One-third (9) patients taking appropriate maintenance doses of Pyrukynd in a second trial had a decrease of at least 33% in the need for blood transfusions over 24 weeks. Six of the patients did not need any transfusions.
• The most common side effects were headaches, insomnia and nausea; which all generally occurred at the start of dosing, but resolved within a few days.
• Designated as an Orphan Drug, Pyrukynd was approved under the FDA’s Fast-Track and Priority Review programs.

Fleqsuvy Receives FDA Approval

A new branded baclofen product, Fleqsuvy™ oral suspension, 5mg/mL, was approved by the U.S. Food and Drug Administration (FDA) on Feb. 4, 2022. Made by Azurity Pharmaceuticals, it is approved to treat spasticity resulting from multiple sclerosis (MS), especially to relieve flexor spasms and concomitant pain, clonus (repeated spasms) and muscular rigidity. It also may be of some value for patients who have injuries or diseases of the spinal cord. Baclofen is a gamma-aminobutyric acid (GABA) receptor agonist that is believed to relax muscles by diminishing nerve conduction in the spinal column. It has been on the U.S. market as tablets and injectable forms since 1977. Doses of Fleqsuvy should start at 1mL (5mg) three times a day and then increase by 1mL per dose three times a day every three days until the lowest effective dose or a maximum of 4mL four times a day (80mg) is reached. If Fleqsuvy needs to be stopped, patients should be tapered off gradually in the same way. The first commercially available baclofen oral solution, Ozobax® (Metacel Pharmaceuticals), was FDA approved in September 2019. Because it has a concentration of 1mg/mL, patients need to take larger volumes of Ozobax to equal the same strength doses as Fleqsuvy. All baclofen products may cause dizziness or drowsiness. Fleqsuvy’s launch and cost plans have not yet been released.

Volbella XC Approved for New Indication

On Feb 8, 2022, Allergan Aesthetics, one of AbbVie’s group of companies, announced that the FDA has approved a new indication for Juvéderm® Volbella® XC (hyaluronic acid). One of several products in Allergan Aesthetics’ line of cosmetic dermal filler products, it now is indicated to improve infraorbital hollows (depressions under the eyes) for patients over 21 years of age. It first was FDA approved in 2016 to augment lips and to correct perioral rhytids (lines around the lips) for patients in the same age group. Juvéderm products use a proprietary technology that mixes different types of hyaluronic acid. Using a very thin needle or cannula, the resulting gel is injected subcutaneously (SC) directly into the affected areas by a healthcare professional specially trained in its use. It is packaged in prefilled, single-dose syringes. In studies, Volbella XC’s smoothing effects lasted as long as 12 months for some patients. Most trial participants experienced generally mild, temporary side effects that included bruising, itching, redness and swelling around the injection sites, and some side effects persisted as long as six weeks. It is distributed directly to plastic surgeons, cosmetic surgeons, and other physicians.

New Dosage Form for Takhzyro

Takeda announced on Feb. 9, 2022, that the FDA had approved ready-to-use, single-dose, prefilled syringes for Takhzyro® (lanadelumab-flyo) injection. Takhzyro is indicated to prevent episodes of hereditary angioedema (HAE) for patients at least 12 years old. Affecting between 6,000 and 10,000 Americans, HAE is a genetic disorder caused by a deficiency of C1 inhibitor. Patients with the disease experience sudden, recurrent, potentially life-threatening inflammatory attacks that cause swelling. The abdomen, arms and legs, face, hands and feet, throat and urogenital tract all can be affected. As the first monoclonal antibody to be approved for HAE therapy, Takhzyro blocks a blood protein, kallikrein, to prevent swelling. It is dosed as one 300mg SC self-injection every two weeks, which may be reduced to one every four weeks if the patient has no attacks for six months. Previously, patients or caregivers had to draw doses of Takhzyro from a vial. Takeda plans to launch the new dosage form later in 2022.

Ruzurgi’s Approval Invalidated

Citing a violation of the Orphan Drug Act, a District Court has ruled that the FDA’s approval for Ruzurgi® (amifampridine –Jacobus Pharmaceuticals) infringes on the seven years of Orphan Drug exclusivity held by Catalyst Pharmaceuticals for Firdapse® (amifampridine). Both drugs are formulated as 10mg tablets used for treating the rare condition — Lambert-Eaton myasthenic syndrome (LEMS). An autoimmune disease, LEMS interrupts the flow of nerve impulses to muscles, resulting in fatigue and weakness, especially in the legs. Ruzurgi was approved in May 2019, for treating patients between six years old and 17 years old. However, Firdapse, which was FDA approved in November 2018, is indicated only for adult patients. The court ruling cancels FDA approval of Ruzurgi, making it ineligible to be sold in the U.S. Under an expanded access program for Firdapse, counselors at Catalyst are working with caregivers, prescribers and insurers of pediatric patients who were taking Ruzurgi to offer them treatment with Firdapse, if possible. Here are links to more information about how to switch from Ruzurgi to Firdapse.

FDA Warnings about More COVID-19 Tests

After previously warning testing site personnel, healthcare providers and patients not to use COVID-19 tests from LuSys (also sold as EagleDx, Luscient Diagnostics or Vivera Pharmaceuticals) and Empowered Diagnostics, the FDA has added more companies to the list of unacceptable tests. E25Bio COVID-19 Direct Antigen Rapid Tests (also called E25Bio SARS-CoV-2 Antigen Test Kits), which were sold directly to individuals, are not approved for use in the U.S. SD Biosensor’s STANDARD Q COVID-19 Ag Home Tests, which are not believed to have reached patients, were imported into the country illegally and they are being recalled. Neither should be used. Providers or patients who suspect results from one of the unapproved COVID-19 tests are false should consider retesting with an FDA-approved product if the test was within about two weeks. Tests administered more than two weeks previously probably do not need to be repeated.