EC grants authorisation to LEO Pharma’s Anzupgo cream

The European Commission (EC) has granted marketing authorisation to Leo Pharma’s Anzupgo (delgocitinib) cream for treating adults with moderate to severe chronic hand eczema (CHE).

The cream is indicated for use in CHE patients for whom topical corticosteroids are not suitable.

The approval extends to all member states of the European Union, Norway, Iceland and Liechtenstein.

The authorisation for Anzupgo cream is supported by data from the Phase III DELTA 1 and DELTA 2 clinical trials, which assessed the safety and efficacy of the cream versus a vehicle.

Both trials met their primary and all secondary endpoints.

LEO Pharma CEO Christophe Bourdon stated: “We are dedicated to advancing the standard of care for those living with skin conditions, and this long-awaited milestone for Anzupgo demonstrates our purpose in practice.

Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

View profiles in store

Company Profile – free
sample

Your download email will arrive shortly

We are confident about the
unique
quality of our Company Profiles. However, we want you to make the most
beneficial
decision for your business, so we offer a free sample that you can download by
submitting the below form

By GlobalData

Country *
UK
USA
Afghanistan
Åland Islands
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint
Eustatius
and
Saba
Bosnia and Herzegovina

Botswana
Bouvet Island
Brazil
British Indian Ocean
Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic

Chad
Chile
China
Christmas Island
Cocos Islands
Colombia
Comoros
Congo
Democratic Republic
of
the Congo
Cook Islands
Costa Rica
Côte d”Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern
Territories

Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and
McDonald
Islands

Holy See
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kuwait
Kyrgyzstan
Lao
Latvia
Lebanon
Lesotho
Liberia
Libyan Arab Jamahiriya

Liechtenstein
Lithuania
Luxembourg
Macao

Macedonia,
The
Former
Yugoslav Republic of
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands

Norway
Oman
Pakistan
Palau
Palestinian Territory
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Réunion
Romania
Russian Federation
Rwanda
Saint
Helena,
Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Pierre and Miquelon

Saint Vincent and
The
Grenadines

Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South
Georgia
and The South
Sandwich Islands
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen

Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands

Tuvalu
Uganda
Ukraine
United Arab Emirates
US Minor Outlying Islands

Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
British Virgin Islands

US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Kosovo

Industry *

Academia & Education
Aerospace, Defense &
Security
Agriculture
Asset Management
Automotive
Banking & Payments
Chemicals
Construction
Consumer
Foodservice
Government, trade bodies
and NGOs
Health & Fitness
Hospitals & Healthcare

HR, Staffing &
Recruitment
Insurance
Investment Banking
Legal Services
Management Consulting
Marketing & Advertising

Media & Publishing
Medical Devices
Mining
Oil & Gas
Packaging
Pharmaceuticals
Power & Utilities
Private Equity
Real Estate
Retail
Sport
Technology
Telecom
Transportation &
Logistics
Travel, Tourism &
Hospitality
Venture Capital

Tick here to opt out of curated industry news, reports, and event updates from Pharmaceutical Technology.

Submit and
download

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“This approval provides a new treatment option for patients, and we look forward to coordinating the next steps required to provide Anzupgo to those patients who need it.”

The US Food and Drug Administration (FDA) has also accepted the company’s new drug application seeking approval for delgocitinib cream.

A topical pan-Janus kinase (JAK) inhibitor, Anzupgo works by addressing the JAK-STAT signalling pathway implicated in CHE’s pathogenesis.

LEO Pharma holds the sole rights for the development and commercialisation of delgocitinib cream for dermatological uses globally, except in Japan, since the signing of a licensing agreement with Japan Tobacco in 2014.

Japan Tobacco holds the rights to the asset in Japan.

LEO Pharma chief development officer Kreesten Meldgaard Madsen stated: “This approval is the culmination of years of focus and effort, driven every day by the goal to support this patient population.

“The new treatment option aims to support the management of this debilitating condition, given the limited treatment options for CHE currently approved across Europe.”

In June 2024, Leo Pharma received FDA approval for Adbry (tralokinumab-ldrm) single-dose autoinjector for atopic dermatitis.

Sign up for our daily news round-up!
Give your business an edge with our leading industry insights.

Source link : http://www.bing.com/news/apiclick.aspx?ref=FexRss&aid=&tid=66f303783e1847f8b595962a83688c5b&url=https%3A%2F%2Fwww.pharmaceutical-technology.com%2Fnews%2Fec-leo-pharma-anzupgo%2F&c=4859112099904523383&mkt=de-de

Author :

Publish date : 2024-09-24 00:57:00

Copyright for syndicated content belongs to the linked Source.