Drug approvals in Japan | PMDA | MHLW Approvals | News | Media | Japan | iPharmaCenter

September 27, 2022

Keytruda received approval for TNBC, RCC, cervical cancer, and as a monotherapy for melanoma.

Merck announced that Keytruda (pembrolizumab) received four approvals in Japan.

  • Keytruda in combination with chemotherapy, following as monotherapy for patients with hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer

  • As monotherapy for patients with renal cell carcinoma

  • in combination with chemotherapy for cervical cancer with or without bevacizumab

  • as monotherapy for stage IIB or IIC melanoma

Triple-negative breast cancer

The approval was based on the Phase 3 KEYNOTE-522 trial, in which Keutruda, in combination with chemotherapy administered before surgery and continued as monotherapy, significantly reduced event-free survival compared to placebo in combination with chemotherapy. The risk of disease progression and death was reduced by 37% versus placebo.

Renal cell carcinoma

Keytruda was approved as an adjuvant treatment for RCC patients at risk of recurrence following nephrectomy or following nephrectomy resection. The approval was based on the Phase 3 KEYNOTE-564 trial; Keytruda as an adjuvant treatment reduced the risk of disease recurrence or death by 32% versus placebo.

Advanced cervical cancer

Keytruda was approved in combination with chemotherapy, with or without bevacizumab, for advanced or recurrent cervical cancer who were not treated previously with chemotherapy. The approval was based on the Phase 3 KEYNOTE-826 trial, in which Keytruda plus chemotherapy, with or without bevacizumab, showed significant improvement in overall survival of 33% and reduced the risk of disease progression or death by 35% versus chemotherapy with or without bevacizumab.

Stage IIB or IIC melanoma

Keytruda received label extension for patients with stage IIb or IIC melanoma. The approval was based on the Phase 3 KEYNOTE_716 trial, in which Keytruda significantly prolonged recurrence-free survival, reducing the risk of disease recurrence or death by 35% versus placebo.



September 27, 2022

Bayer's Eylea approved for preterm infants with retinopathy of prematurity

The Ministry of Health, Labour and Welfare (MHLW) in Japan approved Bayer's Eylea (aflibercept) for the treatment of preterm infants with retinopathy of prematurity (ROP).

The approval was based on the FIREFLEYE study and extension study. In the treatment, intravitreal treatment of Eylea 0.4 mg was effective, safe, and well tolerated. 85.5% of patients receiving Eylea 0.4 mg showed no ROP at 24 weeks versus 82.1% of patients treated with laser photocoagulation.

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September 27, 2022

Koselugo approved for pediatric patients with plexiform neurofibromas (PNs) in neurofibromatosis type 1 (NF1)

AstraZeneca announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Koselugo (selumetinib) for treating pediatric patients with plexiform neurofibromas (PNs) in neurofibromatosis type 1 (NF1).

The approval was based on the SPRINT Stratum 1 Phase II trial; Koselugo demonstrated an objective response rate (ORR) of 66% if administered twice daily as monotherapy.

NF1 is conditional in which soft lumps will be formed on and under the skin. This can cause disfigurement, motor dysfunction, pain, visual impairment, and bowel dysfunction. The life expectancy can be reduced by up to 15 years.

 

August 25, 2022

Tagrisso approved for early-stage EGFR-mutated lung cancer in Japan

AstraZeneca announced that Japan's Ministry of Health, Labour and Welfare approved Tagrisso (osimertinib) for treating patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery.

The approval was based on the Phase 3 ADAURA trial. The primary endpoint was disease-free survival (DFS). After 24 months of treatment in patients with stage II to IIIA disease, 90% of patients on osimertinib and 44% on placebo were alive and disease-free.

Tagrisso acts by inhibiting EGFR-TKI sensitizing and EGFR p.



 

May 31, 2022

GSK announced the approval of Vocabria in combination with Rekambys

GSK announced that Japan's Ministry of Health, Labour, and Welfare approved Vocabria (cabotegravir) in combination with Rekambys (rilpivirine). This reduces the drug administration from 365 times a year to 6 or 12 times a year.

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Based on the global HIV-patient reported outcome studies, patients prefer to have therapies that require fewer administrations.

It was estimated that nearly 30,000 people are living with HIV in Japan.



 

April 19, 2022

Nuvaxovid, another COVID19 vaccine, was approved for primary and booster immunization.

Takeda announced that Nuvaxovid, a COVID19 vaccine, was approved in Japan for primary and booster immunization. Nuvaxovid is a recombinant protein-based COVID19 vaccine that contains Matrix-M adjuvant.

The Japan Ministry of Health, Labour and Welfare (MHLW) approved the vaccine based on one Phase 1/2 trial conducted in Japan in addition to the other trials conducted in the US, Japan, and Europe.

Takeda announced that the vaccine can be stored at 2-8 C.

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Bristol-Myers Squibb's Abecma received approval for multiple myeloma.

Japan's Ministry of Health, Labour, and Welfare approved Bristol-Myers Squibb's Abecma (idecabtagene vicleucel) for treating adult patients with relapsed or refractory multiple myeloma. Abecma is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell, which is indicated for patients who were previously treated with other three drugs (an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody).

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The approval was based on the global Phase 2 Study BB2121-MM-001, which included the patients from Japan, the US, Canada, and the EU. The overall response rate was 73.4% in the global Phase 2 Study BB2121-MM-001. The overall response rate in Japanese patients was 88.9%.


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Further, the company also submitted the CRB-401, a Phase 1 study that enrolled patients only from the US.




Japanese MHLW approved Keytruda plus Lenvima combination for endometrial carcinoma

Merck and Eisai announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination for patients with endometrial cancer. The combination is approved for patients with unresectable, advanced, or recurrent endometrial carcinoma who are prior treated with chemotherapy.

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The approval is based on the Phase 3 KEYNOTE-775/Study 309 trial, in which the combination of Keytruda plus Lenvima was evaluated versus chemotherapy. Keytruda plus Lenvima combination showed improvement in the overall survival; the risk of death was reduced by 38%. The risk of progression or death was decreased by 44% versus chemotherapy. The median progression-free survival was 7.2 months 3.8 months in the chemotherapy arm (doxorubicin or paclitaxel).

The combination is approved in the US and Europe for endometrial cancer. Both the drugs have received orphan designation in Japan for endometrial cancer.

Endometrial cancer originates in the uterus's endometrium, which accounts for 90% of uterine cancers.




After EMA, one more disappointment from Japan to Biogen as regulators asked more data for Aduhelm approval

Eisai and Biogen have announced that Japan's First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation asked for more information for the approval of aducanumab.

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The companies announced that they would engage with the Pharmaceuticals and Medical Devices Agency (PMDA) on the required additional data.

This comes after the negative CHMP opinion in the European Union for approval in Europe. Only the US FDA approved the product; however, the experts raised concerns over the efficacy. ICER and experts criticized the price.



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Japan's MHLW approved Merck's molnupiravir to treat COVID19

Merck and Ridgeback Biotherapeutics announced that Japan's Ministry of Health, Labor, and Welfare approved molnupiravir for treating SARS-CoV-2 infection.

The approval is under Article 14-3 of the Pharmaceuticals and Medical Devices Act. Merck agreed to supply 1.6 million courses of molnupiravir to the government of Japan.


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The approval is based on the MOVe-OUT Study. Molnupiravir is given 800 mg twice daily in non-hospitalized COVID19 infection patients with mild-to-moderate symptoms. The primary endpoint was to evaluate the efficacy of molnupiravir versus placebo at day 29. At the interim analysis, 14.1% of patients who were on placebo were either hospitalized or died, whereas, in the molnupiravir arm, 7.3% of patients were hospitalized. At the point of interim analysis, no death was reported in the molnupiravir arm compared to eight deaths in patients who were on placebo.

In all random analyses, a relative reduction in the risk of death is 89% - nine deaths were reported in the placebo arm (29-day all-cause mortality is 1.3%). Only one death was reported in the molnupiravir arm (29-day all-cause mortality is 0.1%).

Diarrhoea, nausea, dizziness, and headache were the most common adverse events.

The drug was approved in the USA, UK, and Japan. It has received positive CHMP opinion in the European Union. The drug is available under the brand name Lagevrio.



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