The approval follows P-III trials (PROMISE-1 in episodic migraine & PROMISE-2 in chronic migraine) assessing Vyepti vs PBO in 2,076 adult patients for the preventive treatment of migraine who have at least 4 migraine days/mos.
The studies met its 1EPs of decrease in mean monthly migraine days (MMD) over 1-12wks and showed 50% & 75% responder rates & good tolerability
Vyepti is a humanized mAb that binds to calcitonin gene-related peptide (CGRP)
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Novartis’ injectable migraine prevention antibody Aimovig has been shown to be more effective than topiramate – a go-to oral therapy for people with chronic migraine – in a head-to-head trial.
The HER-MES trial found that Aimovig (erenumab) was more effective at preventing migraine attacks and also better tolerated than topiramate, a generic epilepsy drug which is known to have side effects like sleepiness, dizziness, diarrhoea and nausea.
In the 777-patient study, fewer patients on Novartis’ drug discontinued treatment due to side effects, while more of them met the objective of a 50% reduction in the number of days in a month they had a migraine compared to high-dose topiramate.
Topiramate also needs to be taken twice a day, while Aimovig is given as an injection once a month and is available in a self-injector pen device. Both drugs can take up to three months for their effect on migraine prevention to fully kick in.
Novartis recorded Aimovig sales of $108 million in the first nine months of 2020, a rise of 44% on the same period of 2019, and says it is the most prescribed drug in the CGRP inhibitor class with 480,000 patients using it worldwide.
Quarterly sales have however fallen from a strong launch in 2018, and the drug can’t seem to generate the momentum needed to meet blockbuster sales expectations voiced during its development.
Part of that is the entry into the market of CGRP rivals, with three injectable drugs (Teva’s Ajovy and Eli Lilly’s Emgality) and one six-monthly infusion (Lundbeck’s Vyepti) now jostling for position in the migraine prevention market.
Meanwhile, two oral CGRP inhibitors – AbbVie’s Ubrelvy and BioHaven’s Nurtec – have been launched for the on-demand treatment of acute migraine attacks. These don’t compete with Aimovig and the other prevention therapies directly, but are raising the profile of the CGRP class among migraine sufferers and their doctors.
This year of course there have also been access issues caused by the coronavirus pandemic that have had a particularly big impact on neurology prescribing, as well as a continued challenge in persuading doctors to switch to the new class from older drugs like topiramate and AbbVie/Allergan’s Botox.
It’s estimated that CGRP drugs have only penetrated 15% of the migraine prevention market, and that’s why the HER-MES results are so important to Novartis.
“These results further emphasise its potential to provide significant relief from migraine with an infrequent dosing compared with the oral treatment,” said Estelle Vester-Blokland, the company’s global head of neuroscience medical affairs.
The company has exclusive rights to the sell Aimovig outside the US, where Amgen records sales, with the exception of Japan. Novartis and Amgen are however locked in a legal battle over marketing rights to the drug.
An implantable neurostimulation migraine device from Salvia BioElectronics has gained Breakthrough Device Designation from the FDA.
Traditional neurostimulation systems are not designed to be compatible with the anatomy of the head, so Netherlands-based Salvia has developed flexible bioelectronic foils (pictured) that could be inserted below the skin in a minimally invasive procedure.
Breakthrough Device designation is reserved for potential products that could offer an improvement over existing therapies for a serious disease, in terms of safety and efficacy.
The designation allows Salvia to have more frequent interactions with FDA regulators when preparing filings, with the possibility of a faster review of trial data.
The decision from the FDA follows Salvia’s 26 million euro ($30 million) fundraiser in September to fund further development of the therapy.
Migraine is the first cause of disability in under 50s, affecting one out of seven people, predominantly women.
People with migraine experience episodes of throbbing, pulsating pain, sometimes accompanied by nausea, vomiting, and sensitivity to light, that can last anywhere from a few hours to a few days.
More than 5% of patients suffer from chronic migraine, where they experience migraines for an average of 22 days per month.
The Series A investment round was led by Panakès Partners, INKEF Capital and SHS Gesellschaft für Beteiligungsmanagement with participation from BOM Brabant Ventures, Thuja Capital and Dolby Family Ventures.
The total raised includes a 5m ($5.78 million) euro deferred risk-bearing Innovation Credit from the Netherlands Enterprise Agency (RVO, part of the Dutch ministry of Economic Affairs and Climate Policy).
A group of drugs known as calcitonin gene-related peptide (CGRP) inhibitors have recently been approved to prevent or reduce attacks.
However there has been limited progress to find new treatments for migraines for patients with chronic disease.
The most common treatments are antidepressants, beta blockers, anti-seizure medications, painkillers and even botulinum toxin.
Denmark’s Lundbeck has beat its expectations in third quarter results, following a strong performance from its portfolio of mental health drugs, although its newly-launched migraine drug seems to have got off to a slow start.
Lundbeck posted quarterly sales of 4.46 billion Danish kroner ($693.39 million), which Reuters noted beat expectations of around 4.39 billion kroner expected by analysts in a poll compiled by Refinitiv.
The performance was thanks to increased sales of its mental health drug Abilify Maintena, which increased 19% in the first nine months of the year compared with the same period last year to 1.729 billion Danish kroner ($270 million).
Sales of its depression drug Trintellix increased 14% to 2.3 billion kroner ($360 million) over nine months.
Another of the company’s mental health drugs, Rexulti (brexipiprazole) for maintenance treatment of schizophrenia saw sales increased by 24% to just over 2 million Danish kroner ($310 million).
The company also has high hopes for its Vyepti migraine drug, although this has only produced sales of 42 million Danish kroner ($6.5 million) since its launch in the US in March.
Lundbeck added Vyepti to its portfolio following its acquisition of Alder in a deal worth up $1.95 billion in September last year.
The last in a gang of four calcitonin gene-related peptide (CGRP) drugs to be approved, Alder decided to develop Vyepti as an intravenous drug that is administered in hospital instead of using pens where patients administer doses themselves.
While the self-administered rivals from Amgen/Novartis, Eli Lilly and Teva that were already on the market at the time of approval may have an advantage in terms of convenience, Lundbeck hopes its IV drug will be more popular with payers.
CEO Deborah Dunsire said that patient feedback about Vyepti had been “strongly positive” and noted its fast onset may also give it the edge over rivals.
Lundbeck upwardly revised full-year earnings before interest and tax (EBIT) to come in between 2 billion crowns and 2.2 billion Danish kroner, up from a previous estimate of 1.8 billion kroner to 2 billion kroner.
Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data.
Qtrypta takes the form of a transdermal patch loaded with zolmitriptan, a well-established medicine for acute migraine that has been available for years in various formulations including tablets and nasal sprays.
Zosano’s product uses microneedles to help the drug get absorbed into the blood, but the Complete Response Letter (CRL) from the FDA says it is concerned about inconsistencies in how much zolmitriptan was being delivered with Qtrypta.
Specifically, the FDA pointed to differences in zolmitriptan exposures between subjects receiving different lots of Qtrypta in the company’s trials, including some unexpectedly high results in five individuals.
It also mentions “inadequate pharmacokinetic bridging between the lots that made interpretation of some safety data unclear.”
The CRL comes just a couple of weeks after Zosano received a discipline review letter (DRL) from the FDA, a preliminary sharing of the agency’s stance, after which the company had already said it did not expect approval by the action date of 20 October.
Shares in the Nasdaq-listed biopharma lost around 25% of their value after the announcement, as investors tried to gauge how long the programme might now be delayed, and the implications for its delivery platform, which is the first microneedle patch to be Included in a new drug application to the FDA.
Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.
The FDA wants a new bioequivalence study between three of the Qtrypta lots tested during development, as well as product quality validation data, originally due to be filed after approval, as part of the new drug application (NDA).
The agency also says that inspection of Zosano’s contact manufacturing facilities for the product – while currently on hold because of the pandemic – will also have to be completed before Qtrypta can be approved.
That suggests the delay could be some time, but Zosano is keeping tight-lipped until it has a chance to meet with the FDA to discuss a way forward for the programme.
“We are working diligently to address the deficiencies identified by the FDA and look forward to the possibility of resubmitting our NDA,” said the company’s CEO Steven Lo.
“There are thousands of people suffering from migraine attacks that are not adequately addressed with available drugs, and we continue to believe that Qtrypta, if approved, could offer a much-needed new therapy for these patients,” he added.
The company has previously reported data showing that Qtrypta can deliver fast relief from a migraine with fewer than 2% of patients experiencing side effects common with triptan drugs, like dizziness and pins and needles.
Zosano recently signed a five-year deal worth $250 million deal with Eversana to commercialise and distribute Qtrypta if gets past the FDA.
An oral nonopioid analgesic is often sufficient for acute
treatment of mild to moderate migraine headache
without severe nausea or vomiting. A triptan is the
drug of choice for treatment of moderate to severe
migraine headache pain in most patients without
vascular disease. Early treatment of pain when it is
still mild to moderate in intensity improves headache
response and reduces the risk of recurrence.