Tag: EMA

 

EMA Panel Backs Peanut Allergy Desensitizing Powder Palforzia

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended on October 15 that marketing authorization be granted for Palforzia (Aimmune Therapeutics). The product is intended for desensitizing children and adolescents to peanut allergy.

Palforzia will be available as an oral powder in capsules (0.5, 1, 10, 20, and 100 mg) and as oral powder in sachet (300 mg). The active substance is defatted powder of Arachis hypogaea.

Through use of the product, children with a peanut allergy receive controlled exposure to precise, increasing amounts of peanut protein, mixed with soft food, every day. Over time, this may help to decrease their sensitivity to small amounts of peanuts.

According to the press release from the EMA, Palforzia can mitigate accidental exposure to small amounts of peanut protein. “[A] single dose of a least 1 gram of peanut protein would cause no more than mild allergy symptoms,” the EMA said.

The treatment is indicated for patients aged 4 to 17 years who have received a confirmed diagnosis of peanut allergy. Treatment may be continued for patients aged 18 years or older, according to the press release.

It should be administered under the supervision of a healthcare provider qualified in the diagnosis and treatment of allergic diseases and should be used in conjunction with a peanut-avoidant diet, the EMA notes.

The most common side effects that have been reported are abdominal pain, throat irritation, itch, nausea, vomiting, urticaria, and upper abdominal discomfort.

The next step in the approval process is to obtain market authorization from the European Commission. Detailed recommendations for use will be described in the summary of product characteristics, which will be published in the European public assessment report and will be made available throughout Europe.

“We are encouraged by the CHMP opinion, which recommends Palforzia as the first and only treatment option in the European Union for patients with peanut allergy and their families,” Andrew Oxtoby, president and chief executive officer of Aimmune Therapeutics, said in a statement. “Today’s decision underscores the strong and compelling data from our Palforzia clinical trials and follows the US FDA approval of Palforzia earlier this year. We look forward to the European Commission’s final decision for the marketing approval of Palforzia, which we expect later this year.”

The FDA said in granting its approval that patients, parents, or caregivers must be counseled on the need for always-available injectable epinephrine, the need for continued peanut avoidance, and on how to recognize signs of anaphylaxis.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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EMA Recommends First Long-Acting Injectable HIV Treatment

The first long-acting injectable treatments for HIV were recommended for marketing approval on October 16 by the European Medicines Agency (EMA).

A combination injection of two new antiretroviral (ARV) medicines, rilpivirine (Rekambys) and cabotegravir (Vocabria) was recommended by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Instead of daily pills, patients would receive intramuscular injections monthly or bimonthly.

The combination injection is meant as maintenance therapy for adults with undetectable HIV levels (viral load <50 copies/mL) with their current ARV treatment and for those in whom the virus has not developed resistance to nonnucleoside reverse transcriptase inhibitors and integrase strand transfer inhibitors, according to the EMA.

According to a press release, the most common side effects are injection site reactions, headache, fever, nausea, fatigue, abnormal lack of energy, myalgia, and dizziness.

The CHMP opinion will now be sent to the European Commission for decision on a European Union–wide marketing authorization. Once granted, price and reimbursement decisions will be made for each country.

The standard treatment for HIV is a combination of ARVs from at least two classes that must be taken daily to suppress viral replication, increase number of CD4 cells, and stop disease progression.

“For some HIV-infected people treated with a stable and effective daily combination of ARV medicines, the availability of a long-acting ARV that reduces the dosing frequency presents a significant improvement by increasing overall satisfaction with treatment and reducing the burden associated with daily pill taking,” the EMA noted.

The two drugs work together to block the ability of the virus to replicate, the EMA explained in the press release. The long-acting injectable regimen does not cure HIV but helps reduce the amount of the virus and keep it at a low level.

The CHMP opinion was based on three phase 3 randomized, open-label, multicenter clinical trials with HIV-infected, treatment-naive or successfully treated adults. The studies demonstrated the safety and efficacy of the combination injection regimen when administered every 4 or 8 weeks.

More efficacy and safety data will be collected through a prospective cohort study and a 5-year study to assess real-world use. Postmarketing safety reports will publicize the results.

The World Health Organization reports that 38 million people were living with HIV worldwide in 2019. During the past 30 years, more 2.3 million people with HIV have been reported in the WHO European Region.

The US Food and Drug Administration declined to approve the injectable combination in December.

According to ABC News, the FDA was concerned about the manufacturing process, not the efficacy or safety of the combination.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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EMA OKs First CAR T-Cell Therapy for Mantle Cell Lymphoma

The European Medicines Agency (EMA) today recommended granting conditional marketing authorization to brexucabtagene autoleucel (Tecartus), making it the first approved chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) in the European Union.

Brexucabtagene autoleucel is the third CAR T-cell therapy to be recommended for approval in Europe, but the only one for this indication.

The agent was approved for the same use in the United States earlier this year and was described by one expert as representing a “new frontier” in the treatment of MCL.

The new agent addresses an unmet need in MCL for patients who relapse or progress despite available therapies.

The current standard of care for this cancer includes stem cell transplantation and various therapy regimens, including Bruton’s tyrosine kinase (BTK) inhibitors, all of which are often initially effective. However, patients commonly relapse or stop responding to treatment, according to the EMA.

“This opinion is an important milestone for patients in Europe living with relapsed or refractory mantle cell lymphoma,” said Ken Takeshita, MD, global head of clinical development at Kite, the agent’s manufacturer, in a press statement.

It is based on safety and efficacy results from the multicenter, single-arm ZUMA-2 trial in 74 adult patients with refractory or relapsed MCL who had received at least two prior therapies.

During the study’s 12-month follow-up period, 84% of patients had a partial response and 59% had a complete response.

The most common side effects are cytokine release syndrome, infections, and encephalopathy. Monitoring and mitigation strategies for these side effects are described in the product information and the agent’s risk management plan.

Further efficacy and safety data are being collected as part of long-term follow-up from the pivotal study and an additional registry-based study.

Brexucabtagene autoleucel was supported through EMA’s Priority Medicines (PRIME) initiative, which provides early and enhanced scientific and regulatory support to medicines that have the potential to address unmet needs.

Nick Mulcahy is an award-winning senior journalist for Medscape. He previously freelanced for HealthDay and MedPageToday, and had bylines in WashingtonPost.com, MSNBC, and Yahoo. Reach him by email and follow him on Twitter.

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