Industry news

FDA declines to approve Avenue’s intravenous use of tramadol

15 June | regulation

The US Food and Drug Administration (FDA) has declined to approve Avenue Therapeutics’ new drug application (NDA) for intravenous (IV) use of analgesic tramadol for a second time.

In its second complete response letter (CRL) to the company, the FDA said that the delayed and unpredictable onset of analgesia with IV tramadol did not support its use as a monotherapy for treating patients in acute pain.

The FDA also noted the inadequate data supporting the usage of IV tramadol with other analgesics as a safe and effective option to treat the intended patient population.

The agency did not notify any chemistry, manufacturing and controls issues in the latest CRL.

Avenue does not agree with the FDA’s interpretation of the data provided in the NDA and plans to seek regulatory approval for IV tramadol.

A speciality pharmaceutical company, Avenue focuses on developing IV tramadol as a probable substitute to lower the use of standard opioids for treating people with acute pain in the US.

In October last year, the FDA declined to approve IV tramadol, stating in a CRL that the drug is not safe for treating patients with acute pain who need an opioid.

According to the FDA, if a patient with acute pain needs an analgesic between the first IV tramadol dose and the onset of analgesia, a rescue analgesic would be required.

15 june | Approvals

HUMANIGEN STARTS ROLLING SUBMISSION FOR COVID-19 DRUG IN THE UK

Humanigen has commenced a rolling review submission to the UK Medicines and Healthcare Products Regulatory Agency (MHRA), seeking marketing approval for its drug candidate, lenzilumab.

A monoclonal antibody, lenzilumab is designed to neutralise granulocyte-macrophage colony-stimulating factor.

This development comes after the company applied for emergency use authorisation (EUA) of the drug by the US FDA.

The latest application to the MHRA is based on favourable results from the Phase III LIVE-AIR clinical study.

Data from this trial showed that lenzilumab met the primary goal with a 54% relative improvement in the chances of survival without ventilation (SWOV) versus placebo.

In participants receiving both corticosteroids and remdesivir, lenzilumab provided a 92% improvement in relative chances of SWOV.

14 june | manufacturing

MODERNA’S NEW COVID-19 VACCINE PRODUCTION FACILITY GETS EMA APPROVAL

Moderna has received the European Medicines Agency’s (EMA) committee for human medicines (CHMP) approval for a new production facility in Monts, France, to manufacture its Covid-19 vaccine.

To be operated by Recipharm, the Monts site will manufacture the finished vaccine product.

Apart from the production site, the CHMP also provided a positive opinion on adding more alternative facilities for batch control or testing activities.

Earlier this month, the panel approved Moderna’s facility located in Norwood, US and Lonza Biologics’ Portsmouth, US plant.

These two US sites will produce active substance and finished product required for Moderna’s Covid-19 vaccine.

Such developments will permit the manufacturing of an additional one to two million doses of ready-to-use vaccine per month for the EU market.

14 june | regulation

FDA AUTHORISES J&J COVID-19 VACCINE SUBSTANCE MADE AT EMERGENT’S PLANT

The US FDA has approved, under the EUA, two batches of Johnson & Johnson (J&J) subsidiary Janssen’s Covid-19 vaccine drug substance produced at the Emergent BioSolutions’ plant in Baltimore, US.

FDA’s decision comes after a thorough review and is part of the agency’s vital measures to make the Covid-19 vaccine available.

Nearly ten million doses of the vaccine were authorised for use by the regulator, which also asked J&J to throw away several million doses manufactured at the Baltimore factory after finding that they were not fit for use.

In April, the FDA released a report citing several unsanitary practices, including peeling paint, shoddy clean-ups and poorly trained staff at the Baltimore facility of Emergent, which is producing the vaccine.

The agency has so far not included the Baltimore plant in the Janssen EUA as an authorised manufacturing site.

As per the latest decision, the Covid-19 vaccine made with the drug substance from the Baltimore site can be used in the US or exported to various other countries.

11 june | supply chain

PFIZER AND BIONTECH TO DELIVER 500 MILLION COVID-19 VACCINE DOSES TO THE US

Pfizer and BioNTech have agreed to provide 500 million doses of their Covid-19 vaccine to the US Government at a not-for-profit price.

These Covid-19 vaccine doses will be donated to about 92 low and lower-middle-income countries and economies and the 55 member states of the African Union.

The companies will initially provide 200 million doses this year and the remaining 300 million doses in the first half of next year.

The doses will be supplied through the COVAX facility, which was established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations and the World Health Organization.

Pfizer stated that the doses are part of a previous commitment to deliver two billion Covid-19 vaccine doses to low and middle-income countries over the coming 18 months.

Pfizer CEO and chairman Albert Bourla said: “Our partnership with the US Government will help bring hundreds of millions of doses of our vaccine to the poorest countries around the world as quickly as possible.

“Covid-19 has impacted everyone, everywhere, and to win the battle against this pandemic, we must ensure expedited access to vaccines for all."

11 june | approvals

OCUGEN TO SEEK FULL APPROVAL FOR BHARAT BIOTECH’S COVAXIN IN THE US

Ocugen has plans to seek full approval for Bharat Biotech’s Covid-19 vaccine candidate, Covaxin, in the US, after the FDA declined to grant an EUA.

Ocugen received feedback on its previously submitted Master File from the US FDA, which recommended the submission of a biologics license application (BLA) instead of a EUA application for the vaccine candidate.

The regulator also requested that the company provide additional information and data.

Currently, Ocugen is in talks with the FDA about the further information needed to support a BLA submission. The company expects the necessity for an additional clinical trial to support the application.

Ocugen CEO, co-founder and board chairman Dr Shankar Musunuri said: “Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path.

“While this will extend our timelines, we are committed to bringing Covaxin to the US.”

Covaxin was developed by India-based Bharat Biotech in alliance with the Indian Council of Medical Research – National Institute of Virology. It is a purified and inactivated vaccine produced using a vero cell manufacturing platform.

In brief

MCureX and Samyang sign MoU for mRNA vaccine development

OliX Pharmaceuticals’ subsidiary mCureX has entered a memorandum of understanding (MoU) with Samyang Holdings to develop a messenger ribonucleic acid (mRNA) vaccine for Covid-19.

The companies are co-developing a vaccine that could potentially target Covid-19 viral variants.

Argenx to regain rights to cusatuzumab from Janssen’s Cilag

Janssen Pharmaceutical subsidiary Cilag International has decided to discontinue its partnership and licence agreement with argenx for an investigational CD70-targeting antibody, cusatuzumab.

The development comes after Janssen reviewed all available data linked to cusatuzumab and considered the transforming standard of care for AML treatment.

Serum Institute obtains DCGI nod to produce Sputnik V vaccine in India

The Drug Controller General of India (DCGI) has granted approval to the Serum Institute of India to produce Russia’s Covid-19 vaccine, Sputnik V, in the country.

Based on an adenovirus vector, the vaccine is given in two doses with a gap of 21 days.

FDA updates Regeneron’s Covid-19 antibody EUA to lower dose

The US FDA has updated the EUA for Regeneron Pharmaceuticals’ Covid-19 antibody cocktail, REGEN-COV, reducing the dose to 1,200mg from 2,400mg.

Bristol Myers faces $6.4bn lawsuit over cancer drug delay

UMB Bank, a trustee for Celgene’s former shareholders, has filed a lawsuit against Bristol Myers Squibb for allegedly delaying the development and manufacturing of cancer drug lisocabtagene maraleucel (Liso-cel) to avoid contingent value right payments worth $6.4bn.

10 june | approvals

VERTEX’S TRIKAFTA GETS FDA APPROVAL TO TREAT CYSTIC FIBROSIS IN CHILDREN

Vertex Pharmaceuticals has secured the US FDA approval for its Trikafta drug to treat cystic fibrosis in children aged six to 11.

The approval is for children with a minimum of one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that responds to the drug based on in vitro data.

In 2019, Trikafta received the FDA nod for use in cystic fibrosis patients aged 12 years and above. It also holds approvals in other countries, including Australia, the UK and the EU.

The company assessed the drug’s safety, efficacy and pharmacokinetics in 66 children aged six to 11 that participated in a 24-week, open-label, multi-centre Phase III clinical trial.

Participants had either two F508del mutation copies or one F508del mutation copy and one minimal function mutation.

09 june | drug discovery

SCIPHER MEDICINE IDENTIFIES NEW COVID-19 DRUG DISCOVERY APPROACH

Scipher Medicine and its partners have identified a new approach that could cut the Covid-19 drug discovery timeline from years to months.

In partnership with Northeastern University, Brigham and Women’s Hospital, Harvard Medical School and Boston University’s National Emerging Infectious Diseases Laboratories in the US, Scipher detected new drug opportunities for Covid-19.

This new method can be leveraged to quickly discover drugs for new and developing viruses.

The partners integrated a network biology and an artificial intelligence platform with clinico-genomic patient data and were able to reduce the duration of research to detect Covid-19 treatments from three years to just two months.

The latest approach is considered crucial progress in creating and testing efficient therapies against diseases, compared to standard methodologies that fail to meet the needs to rapidly develop cures for emergent diseases.

During the studies, the researchers detected repurposing opportunities that target the human proteome with a success rate of 62%.