FDA Approves Teva’s Ajovy Autoinjector
“The approval of the Ajovy autoinjector is another important step forward for Teva and the migraine community,” said Brendan O’Grady, executive Vice President, North America Commercial, Teva. “Ajovy is the only FDA-approved anti-CGRP that offers the flexibility of quarterly (675 mg) or monthly (225 mg) dosing options, and we are pleased that patients and their healthcare providers will be able to decide if an autoinjector is the right administration option for their needs.”
Ajovy is used for the prevention of migraine in certain adults. The drug has been recommended for those who have at least four migraine days per month, and for whom multiple preventative treatments have previously not worked.
With the new FDA approval, Teva will be able to package and make its medicine available in an autoinjector, which most patients prefer, in the next a few months.
Safety Alert Issued for Novartis’ Beovu
Last month, the American Society of Retina Specialists (ASRS) sent out a safety update to doctors detailing 14 cases of retinal vasculitis for Beovu patients. Eleven of the cases were occlusive retinal vasculitis that can lead to vision loss. Since the FDA approval for Beovu to treat wet age-related macular degeneration (AMD) occurred only in October, many of the patients had only their first or second injection of the drug.
Novartis said Beovu’s prescribing information describes a 4% risk of intraocular inflammation and a 1% rate of retinal artery occlusion. The company has instructed doctors to advise patients to seek care immediately if they experience redness in the eye, light sensitivity, pain or changes in vision. The drug also should not be used in patients with intraocular inflammation.
Novartis has “engaged an external safety review committee to further evaluate these post-marketing cases,” a spokesman said, adding that the drugmaker would also do its own internal assessment. “Patient safety is of paramount importance,” he said, adding that “we will continue to share details as they become available.”
Following the communication, several doctors said they would stop using the new medicine, preferring instead to stick with wet AMD options including Regeneron’s Eylea and Roche’s Lucentis.
FDA Grants Priority Review for Farxiga
AstraZeneca announced the FDA accepted a supplemental New Drug Application (sNDA) and granted priority review for Farxiga to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction with and without type-2 diabetes.
The decision was based on results from the Phase III DAPA-HF trial, in which the primary composite endpoint was time to the first occurrence of a worsening heart failure event. In the trial Farxiga demonstrated a reduced incidence of the composite outcome of cardiovascular death or the worsening of heart failure versus placebo.
“Farxiga is well established in the treatment of type-2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.” said Mene Pangalos, AstraZeneca’s Executive Vice President, BioPharmaceuticals R&D.
The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.
FDA Grants Fast Track Designation for Jardiance
Boehringer Ingelheim and Eli Lilly announced the FDA granted Fast Track designation for the investigation of Jardiance to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.
Jardiance is used in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. The ongoing EMPA-KIDNEY study is evaluating the effect of Jardiance on the progression of kidney disease and the occurrence of cardiovascular death in adults with established chronic kidney disease with and without diabetes.
“Chronic kidney disease can have a devastating impact on people’s lives. Not only does it cause damage to the kidneys that can eventually lead to the need for dialysis or transplant, but it could also increase the risk of cardiovascular death,” said Mohamed Eid, M.D., M.P.H., M.H.A, vice president, Clinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals. “Chronic kidney disease is a common and deadly condition, and there are still only limited treatment options, which is what motivates us to explore the potential role Jardiance may play in improving outcomes.”
“We recognize the close link between the health of the heart, kidneys and metabolic system, and we have committed to a broad clinical development program assessing the cardiorenal metabolic benefits of Jardiance,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “The Fast Track designation from the FDA is an important step in evaluating the potential of Jardiance to enhance care for those with chronic kidney disease.”
FDA Grants Priority Review to Lynparza
AstraZeneca and Merck announced that a supplemental New Drug Application (sNDA) for Lynparza in combination with Avastin has been accepted and granted priority review by the FDA for the maintenance treatment of women with advanced ovarian cancer whose disease showed a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab.
Regulators based their decision on data from the Phase 3 Paola-1 trial, presented at the European Society for Medical Oncology (ESMO) annual meeting in September, which showed the Lynparza-Avastin combination could reduce the risk of disease progression or death by 41% in patients with or without BRCA mutations.
The Lynparza-Avastin patients went a median 22.1 months without seeing their disease worsen, an advantage of more than six months over the Avastin-placebo combination.
The FDA is expected to make a decision on the application in the second quarter of this year.
FDA Approves New Indication for Ozempic
Novo Nordisk announced the FDA had approved a new indication for Ozempic injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.
The approval is based on the SUSTAIN 6 cardiovascular outcomes trial, which demonstrated that Ozempic statistically significantly reduced the risk of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 26% versus placebo, when added to standard of care in people with type 2 diabetes with increased CV risk.
“There is a well-established link between cardiovascular disease and type 2 diabetes. It’s one of our biggest concerns with type 2 diabetes because even when patients reach their blood sugar targets, the risk of a major adverse CV event remains,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “Today’s milestone establishes Ozempic as an option for patients to help address two critical aspects of managing type 2 diabetes, blood sugar control and cardiovascular risk reduction, in those with known heart disease.”
FDA Approves New Indication for Trulicity
Eli Lilly announced the FDA expanded the approval of Trulicity to include its use for the reduction of major adverse cardiovascular events (MACE) in patients with type 2 diabetes who have established cardiovascular disease or multiple risk factors for developing cardiovascular issues.
The approval was based on the REWIND (Researching cardiovascular Events with a Weekly Incretin in Diabetes) study, which followed patients treated with Trulicity for a median of 5.4 years. The drug reduced the risk of major cardiovascular events such as heart attacks and strokes by 12%. Eli Lilly showed Trulicity worked equally well in patients with established cardiovascular disease as it did in patients who only had cardiovascular risk factors: a 13% reduction in events for both groups.
“For the first time, health care providers can prescribe a diabetes medicine proven to significantly reduce the risk of experiencing a cardiovascular event for people with type 2 diabetes with and without established cardiovascular disease,” said Sherry Martin M.D., vice president, medical affairs, Lilly. “Trulicity can help people achieve their A1C goals and protect them from experiencing a cardiovascular event with a once-weekly, easy-to-use treatment option.”
FDA Decision May Delay Product Application Reviews
The FDA announced it was postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. Drug makers who are awaiting plant inspections to gain approval to launch new drugs will have to wait.
“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” FDA Commissioner Stephen Hahn said in a statement. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government.”
The FDA said it will resume inspections as soon as “feasible.”
“As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed to help advance federal response efforts in the fight against this outbreak,” its statement said.