FDA Approves Omlonti to Treat Glaucoma
The U.S. Food and Drug Administration (FDA) approved Omlonti® (omidenapag isopropyl ophthalmic solution) 0.002% on Sept. 22, 2022. It is a prostaglandin E2 (EP2) receptor agonist that relieves intraocular pressure (IOP) for patients who have open-angle glaucoma or ocular hypertension. About 95% of the estimated 3 million U.S. patients who have glaucoma have the open-angle form of the condition. Men are slightly more likely than women to have it, as are individuals of African or Hispanic heritage. Most cases are diagnosed among patients in their 40s, and the incidence is expected to increase as the general population ages. Damage that glaucoma causes to the optic nerve results in permanent partial or total vision loss if it is not treated. Among ophthalmic drug classes used to treat it are alpha-adrenergic agonists, beta-blockers, carbonic acid blockers, and cholinergic. Additionally, several other prostaglandin eye drops already are available in the U.S. Omlonti works slightly differently from other ophthalmic prostaglandins, however, by stimulating the filtration of aqueous humor through both the frequently used trabecular channel and the previously untargeted uveoscleral system. Like most other drugs used to treat glaucoma, Omlonti’s recommended dose is one drop into the affected eye(s) each evening. Contact lenses should be removed before using them, and at least five minutes should be allowed before any other eye drops are used. Similar to prostaglandin drugs, treatment may darken the eye color and cause changes, such as thickening of the eyelashes. Omlonti will be sold in bottles containing 2.5mL of the drug. Santen Pharmaceuticals and UBE Corp., its development partner for Omlonti, have not yet disclosed their launch or pricing plans. For its full prescribing information, look here.
New Contrast Agents Approved
Elucirem™ (gadopiclenol – Guerbet) injection and Vueway™ (gadopiclenol – Bracco Diagnostics) injection both were approved under Priority Review by the FDA on Sept. 21, 2022. Although the two products were developed jointly, they will be marketed as two separate brands. Both enhance magnetic resonance imaging (MRI) for patients who are two years old and older and who are being scanned for atypical blood vessels associated with growths in the central nervous system (CNS), head and neck, musculoskeletal system, or main part of the body. Their novel formulation of the rare earth metal, gadolinium, has high relaxivity, which means elucirem and Vueway show higher contrast at lower doses. Their results are comparable to those from other contrast agents that contain gadolinium, but at approximately one-half of the dose. As a result, the risk of side effects may be decreased. Their package labeling still carries a boxed warning, though, about a chance that patients who have diminished kidney function may develop nephrogenic systemic fibrosis (NSF), toughening of connective tissues, such as the skin, when either of them is administered. The recommended dose is 0.05mmol/kg given intravenously (IV) at 2mL/sec immediately before the MRI procedure begins. They will be available in varying sizes of single-dose vials and prefilled syringes, as well as in multi-dose vials. Launch plans have not been revealed. Prescribing information is not yet available for Elucirem: Vueway’s is here.
New Ocular Anesthetic
Harrow and Sintetica received FDA approval on Sept. 27, 2022, for a new anesthetic to be used on the eye surface during procedures such as cataract removal. Iheezo® (chloroprocaine ophthalmic gel) 3%, begins to work in less than two minutes and lasts for about 20 minutes after the recommended dose of three drops is instilled into the affected eye by a healthcare professional. Doses can be repeated if necessary, but no more than one instillation was needed by any of the patients who participated in the clinical trials. The most common side effect was temporary dilation of the pupils for about one-quarter of patients who were treated with Iheezo. It will be distributed as individually wrapped single-dose vials containing 24mg of preservative-free chloroprocaine. The manufacturers are aiming for a U.S. market release before May 2023 – primarily to ambulatory surgery centers, ophthalmologists, and retina specialists. Pricing has not been announced. Here is prescribing information for Iheezo.
Additional Biosimilar for Avastin
The FDA approved Vegzelma® (bevacizumab-adcd – Celltrion) on Sept. 27, 2022, as the fourth U.S. biosimilar to Genentech’s Avastin®. It is indicated to treat certain patients who have colorectal (CRC), non-squamous non-small cell lung cancer, glioblastoma, renal cell carcinoma (RCC), cervical cancer, ovarian cancer, fallopian tube cancer or primary peritoneal cancer. For some indications, the drug is used alone; others are treated in combination with various chemo regimens. The administration is by IV infusion at doses of 10mg/kg or 15mg/kg once every two weeks or once every three weeks depending on cancer that is being treated and any other drugs that are being used. Vegzelma is not automatically interchangeable with the branded drug or with any of its other biosimilars – Alymsys® (bevacizumab-maly – Amneal Pharmaceuticals), Mvasi® (bevacizumab-awwb – Allergan/Amgen) and Zirabev™ (bevacizumab-bvzr – Pfizer). IQVIA estimates that US sales amounted to $1 billion for Avastin and $1.6 billion for its biosimilars in the 12-month period through the end of February 2022. Pricing and launch plans are not yet public. Check here for Vegzelma’s full prescribing information.
Dupixent Receives New Indication
Sanofi/Regeneron’s Dupixent® (dupilumab) gained a new indication on Sept. 28, 2022, when it became the first FDA-approved drug to treat adults who have prurigo nodularis. An inflammatory disease of the skin, prurigo nodularis causes extreme itching and a widespread lumpy rash. Believed to result from the immune system and nerve abnormalities, it may be associated with other conditions, such as AIDS, chronic kidney disease (CKD) or diabetes. Many patients also develop mental health conditions as a result of having it. Mainly detected in middle age, prurigo nodularis is more common for African-Americans and women. About 87,000 patients in the U.S. are diagnosed with it, annually, according to the National Organization for Rare Diseases (NORD). Treatment relies heavily on short-term courses of corticosteroids applied to the skin or injected into individual sores, with immunosuppressant drugs reserved for severe or resistant cases. The recommended dose of Dupixent for treating prurigo nodularis is one subcutaneous (SC) loading dose of 600mg followed by one 300mg dose SC every two weeks. At the 24-week mark in clinical trials, between 30% and 39% of patients using Dupixent achieved both a reduction in itching and clear or nearly clear skin as compared with only 9% of patients injecting a placebo. Slightly higher percentages of patients on active treatment reported diarrhea, dizziness, infections, or muscle pain. Dupixent also has indications for treating atopic dermatitis, eosinophilic esophagitis (EoE), certain types of asthma, and chronic rhinosinusitis with nasal polyposis. The new indication was approved under Priority Review. Revised prescribing information is here.
One Indication Withdrawn for Lynparza
AstraZeneca and Merck informed healthcare providers in late August that they have rescinded one of the indications for their jointly developed poly ADP-ribose polymerase (PARP) inhibitor, Lynparza® (olaparib) tablets. It had been approved in December 2014 as monotherapy to treat patients who have deleterious or suspected deleterious germline BRCA mutated (gBRCAm) ovarian cancer and who had been treated with three or more prior lines of chemotherapy (chemo). Results from the SOLO3 clinical study of nearly 400 patients who have that specific type of cancer showed that taking Lynparza as a fourth-line or later therapy actually increased the odds of death by around one-third as compared with chemo, so the indication is now withdrawn. Lynparza retains its indication as maintenance therapy for (gBRCAm) ovarian cancer, as well as its approvals for certain breast, pancreatic, and prostate cancers. For all of them, the recommended dose is 300mg (two tablets) taken twice a day. Its updated prescribing information may be found here.