Over 30 drugs waiting for authorization from the Portuguese National Competent Authority INFARMED

By Marcio Barra

More than 30 new drugs, some with novel mechanisms of action which are already used in other European countries, are currently waiting for authorization by the Portuguese National Competent Authority, some for more than a year. The president of the board of APIFARMA, João Almeida Lopes, in a newspiece on the SIC tv channel commented that he believes these delays are due to economic reasons.

Some of the delays extend over a year, whereas current law sets a 75 day time limit for approval.

Below is a list of the drugs currently waiting for commercialization approval in Portugal:

 

Brand name	Molecule	Indication	Marketing Authorization holder	Reported reason for delay
Zydelig	Idelalisib	Zydelig is a cancer medicine that is used to treat chronic lymphocytic leukaemia (a cancer of a type of white blood cells called B lymphocytes) used in combination with another medicine (rituximab)	Gilead	The first contract proposal was presented by INFARMED in September 2015
Affinitor	Everolimus	Affinitor is a cancer treatment for advanced breast cancer in women who have been through their menopause.	Novartis	Contract was received. Process not yet concluded
Votubia	Everolimus	Used to treat benign tumours caused by the genetic disease tuberous sclerosis	Novartis	Economic study not yet started
Cosentyx	Secukinumab	Moderate to severe plaque psoriasis	Novartis	Parity with the comparator
Cosentyx	Secukinumab	Ankylosing spondylitis when conventional treatments do not work well enough.	Novartis	Economic evaluation not yet started
Xolair	Omalizumab	Chronic urticaria	Novartis	–
OFEV	Nintedanib	Idiopathic pulmonary fibrosis (IPF)	Boehringer-ingelheim	Orphan indication
Vargatef	Nintedanib	Cancer medicine used to treat adults with non-small cell lung cancer.	Boehringer-ingelheim	–
Praxbind	Idarucizumab	Reversal agent for Pradaxa	Boehringer-ingelheim	–
Giotrif	Afatinib	Non-small cell lung cancer	boehringer-ingelheim	–
Xofigo	Radium-223 dichloride	Treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases	Algeta and Bayer	Waiting for a cost minimization analysis from INFARMED. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Stivarga	Bayer	Gastrointestinal stromal tumor	Bayer	Currently under economic evaluation and Waiting the opinion of the Comissão Nacional de Farmácia e Terapêutica
Stivarga	Bayer	Colorectal cancer	Bayer	Reportedly looking for solutions to assure accessibility to patients. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Zytiga	Abiraterone acetate	Treatment of prostate cancer	Janssen	Accelerated approval by the EMA. Recognition of added therapeutic value.
Imbruvica	Ibrutinib	Chronic lymphocytic leukaemia	Janssen	Breakthrough therapy designation by the FDA. Recognition of added therapeutic value.
Imbruvica	Ibrutinib	Mantle cell lymphoma	Janssen	Breakthrough therapy designation by the FDA. Recognition of added therapeutic value.
Olysio	Simeprevir	Chronic hepatitis C	Janssen	Recognition of added therapeutic value. An estimated 300 patients missing Harvoni (sofosbuvir)
Velcade	Bortezomib	Patients with non-previously treated multiple myeloma	Janssen
Velcade	Bortezomib	Previously untreated patients who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant. In this group of patients, Velcade is used in combination with dexamethasone, or with dexamethasone plus thalidomide;	Janssen	Therapeutic standard in all guidelines. Recognition of added therapeutic value.
Sylvant	Siltuximab	Treatment of multicentric Castleman’s disease in adults who tested negative for the human immunodeficiency virus (HIV) and the human herpesvirus-8 (HHV-8)	Janssen	Orphan disease –roughly 9 patients each year. Recognition of added therapeutic value
Sirturo	Bedaquiline	Sirturo is used in combination with other tuberculosis medicines in adults with tuberculosis that is affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, two standard tuberculosis medicines).	Janssen	New molecule for tuberculosis. Orphan disease –roughly 3 patients each year. Recognition of added therapeutic value
lynparza	Olaparib	First oral treatment for women with BRCA-mutated advanced ovarian cancer who have received 3 or more prior chemotherapy medicines	AstraZeneca	Oprhan drug. Currently undergoing economic evaluation. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Toujeo	Insulin glargine injection	Used to treat diabetes in adult patients	Sanofi-Aventis	New formulation. Waiting decision on charges limit.
Keytruda	Pembrolizumab	used to treat adults with melanoma that has spread to other parts of the body or cannot be surgically removed.	Merck	Formal negotiations with INFARMED have begun, and a final proposal has been reached.
Zontivity	Vorapaxar	Used to reduce the occurrence of atherothrombotic events such as further heart attacks or strokes in adult patients who have already had a heart attack. It is given in combination with aspirin and clopidogrel.	Merck	Under pharmacoeconomic evaluation
Isentress	Raltegravir	Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, children,toddlers and infants from the age of 4 weeks	Merck	Under pharmacoeconom ic evaluation
Genoya	Elvitegravir/Cobicista/Emtricitabine/Tenofovir alafenamide	HIV-1	Gilead
Zerbaxa	Ceftolozane and tazobactam.	Antibiotic used to treat adults with complicated (difficult to treat) bacterial infections affecting: ·        tissues and organs within the belly (intra-abdominal infections); ·         the kidneys (pyelonephritis); ·         the urinary tract (structures that carry urine, such as the bladder).	Merck	Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Adempas	Riociguat	It is used to increase the ability to carry out physical activity in adults with Chronic thromboembolic pulmonary hypertension and Pulmonary arterial hypertension	Bayer
Jardiance	Empagliflozin	Type 2 diabetes	Boehringer Ingelheim
Pradaxa´s third indication	Dabigatran etexilate	Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults	Boehringer Ingelheim
Eylea	Aflibercept	Diabetic macular edema	Bayer	Currently in contract negotiation. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Eylea	Aflibercept	Occlusion of the central retinal vein	Bayer	Currently in contract negotiation.
Stelara	Ustekinumab		Janssen	New indication. Equivalent added therapeutic value
Rezolsta	Darunavir / cobicistat	Human immunodeficiency virus type 1 (HIV-1)	Janssen	New fixed association. Equivalent added therapeutic value
Triumeq	Abacavir, dolutegravir and lamivudine	Human immunodeficiency virus type 1 (HIV-1)	ViiV Healthcare	New fixed association. Equivalent added therapeutic value

Encouraging Phase III results point Novartis’ Xolair as a potential new treatment for allergic skin disease

October 07 ,2013 | By Márcio Barra

Peter Frommenwiler/Bloomberg

Xolair (Omalizumab), Novartis Humanized monoclonal IgG anti-IgE antibody for the treatment of moderate to severe persistent asthma, might be heading towards a new therapeutic indication, according to data from a recent trial.

The trial, ASTERIA 1, the last of a series of phase III studies (following GLACIAL and ASTERIA II), showed that the drug is both safe and effective in treating chronic spontaneous urticaria, a chronic condition characterised by red, swollen, itchy and sometimes painful hives or wheals on the skin that can occur without warning and can last for weeks on end. The current approved treatment for this condition consists only of high dosages of antihistamines, with generally limited efficacy.