What does the FDA's orphan designation mean

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[...] therapeutic products (Swiss Medic) grants tHeOrphan drug designationtO medicinal products used for rare, [...] [...]
or chronic diseases that affect no more than five in every 10,000 people in Switzerland and for which no sufficient effective treatment exists.
A.ls Orphan Drugs sdoft the Swiss Health Authority (Swiss Medic) Medicines ffor die Treatment [...] [...]
or chronic illnesses that do not affect more than five out of 10,000 people in Switzerland and for which there is currently no or insufficient treatment option.
[...] Venticute® receivedOrphan drug designationfrom the FDA for [...]
use in patients with severe acute pneumonia
[...]
or aspiration of gastric contents leading to intubation, mechanical ventilation and severe oxygen impairment.
In September 2006 erhielt Venticute® the orphat Drug-Status der FDA [...]
for the use of the preparation in patients with acute
[...]
Respiratory failure resulting from severe acute pneumonia or aspiration of gastric contents that require intubation and mechanical ventilation and that severely impair oxygen uptake.
For the same molecule, the European Medicines
[...] Evaluation Agency (EMEA) has grantedorphan drug designationfOr the treatment of pulmonary hypertension.
For the same active ingredient, the
[...] Europeansche Arzneimittel-Agentur (EMEA) the Orphan DrugStatus (Medicinal products for rare herbsnkunits) [...]
granted for the treatment of pulmonary hypertension.
[...] has receivedorphan drug designationfOr the treatment [...]
of pulmonary arterial hypertension and chronic thromboembolic
[...]
pulmonary hypertension by the EMEA.
[...] from the EMEA the Orphan drug-Status For the Beplot [...]
pulmonary arterial hypertension and chronic
[...]
Preserved thromboembolic pulmonary hypertension.
Kenta Biotech Ltd. announced today the United States
[...] Food and Drug Administration (FDA) has granted"Orphan drug" designationtO Kenta Biotech's fully human monoclonal antibody [...] [...]
treatment of nosocomial pneumonia caused by serotype O11 Pseudomonas aeruginosa.
Kenta Biotech AG announced today that
[...] [...] the drug approval authority (FDA) their pure human monoclonal antibody KBPA 101 the "Orphan Drug"-Designation [...] [...]
nosocomial pneumonia caused by the bacterium Pseudomonas aeruginosa serotype O11.
With this "Drug & Device" concept, aztreonam lysinate can be administered in about a fifth of the time needed for
[...]
conventionally inhaled antibiotics. In 2004,
[...] PARI received anOrphan drug designation(ODD) for inhaled [...]
cyclosporine, an immunosuppressive
[...]
drug that is intended to prevent the body from rejecting lung tissue following a transplant.
With this "Drug & Device" concept, aztreonam lysinate can be applied in about a fifth of the time previously used by inhalation
[...]
Antibiotics is required. 2004
[...] received PARI eine Orphan Drug Designation (ODD) für inhalative [...]
Ciclosporin, an immunosuppressant
[...]
which is intended to prevent transplant rejection after lung transplantation.
THeOrphan drug designationentitles Fresenius market exclusivity for to up to ten years in the European Union [...] [...]
use in ovarian cancer treatment upon marketing approval.
This status secures Fresenius the exclusive right to market removab® in theser indication innerhal [...] [...]
for a period of up to ten years after receiving approval.
Orphan drug designationOffers a number of potential incentives, which [...]
may include waiver of FDA user fees, study design
[...]
assistance, funding for clinical studies, tax credits for clinical research and a seven-year period of U.S. marketing exclusivity if the drug receives US marketing approval.
The recognitionng as drug For selten sorrowen (Orphan Drug) openfnet z. [...]
B. the possibility of exemption from fees
[...]
the FDA, assistance with the design and funding of clinical trials, tax rebates for clinical research, and seven-year market exclusivity if the drug is approved for commercialization in the United States.
BioMarin also receivedorphan drug designationand started a phase I / II [...]
clinical trial in the fourth quarter of 2000 for MPS-VI.
BioMarin heHielt also «Orphan Drug Ofignation »-Status and staredeemed [...]
in the fourth quarter of 2000 a clinical trial, phases I / II, of MPS-VI.
Orphan drug designationwas achieved in Switzerland for the antibody removal in the indications malignant ascites, gastric cancer and ovarian cancer.
In Switzerland the Antikörper Removab in received orphan drug status for the indications of malignant ascites, gastric cancer and ovarian cancer.
The program already has been grantedorphan drug designationin the United States.
Santhera already has orph in the USAat-Drugs-St.atus für Catena® received at MELAS.
As announced in November 2003,
[...] Jerini was grantedorphan drug designationfOr Icatibant [...]
for the treatment of angioedema by
[...]
the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) as well as by the European Agency for the Evaluation of Medicinal Products (EMEA).
[...] received Jerini den orphan Drug Status ffor Iapproxtibant to [...]
Treatment of Inherited Angioedema by both
[...]
from the American health authority FDA (Food and Drug Administration) as well as from the European approval authority (EMEA) (reports from February 11 and November 18, 2003).
A possible strategy suggested by Eurordis to overcome the barriers encountered by OI patients in access to
[...]
treatments is that pharmaceutical companies interested in
[...] developing bisphosphonates for OI seekOrphan drug designation.
To overcome the hurdles that patients with OI face in accessing the drug, Eurordis suggests a possible strategy: companies that take one
[...]
Interest in developing bisphosphonates for OI
[...] should haveen ae Marked as 'Orphan'-Drug atstrive.
[...] already grantedorphan drug designationtO they program.
[...] already have eggne orphan drug designation r the program [...]
Orphan drug designationis awarded to compounds [...]
that offer potential therapeutic value in the treatment of rare diseases,
[...]
defined as those affecting fewer than 200,000 Americans.
D.he "Orphat Drug"-Status wird jenen preparations [...]
awarded having potential therapeutic value for the treatment of
[...]
rare diseases. These are diseases that affect fewer than 200,000 Americans each year.
In addition, last year the European
[...] Commission grantedOrphan drug designationfOr the trifunctional [...]
Antibody removab® to treat patients with ovarian cancer.
At the same time, the European Commission im
[...] reporting year the Orphat Drug status for den trifunctional [...]
Removab® antibody granted for the treatment of ovarian cancer.
After these positive results, Santhera has decided to continue the
[...]
development of Idebenone,
[...] which already receivedorphan drug designation,tO an effective therapy [...]
These results led to Santhera's decision to implement the clinical
[...]
Development of Idebenone that
[...] already zto "Orphan Drug"heklwas advised to continueetzen up to eggeffective [...]
Therapy of Duchenne muscular dystrophy.
Following the recommendation of the European Medicines
[...]
Agency EMEA, the European
[...] Commission has grantedOrphan drug designationfOr the protease [...]
inhibitor Elafin, developed by
[...]
Proteo, to be used in the treatment of esophagus carcinoma.
On the recommendation of the European Medicines Agency EMEA, the European Commission has approved the
[...] [...] protease inhibitor Elafin die Orphan Drug Designation For die treatment [...]
of esophageal carcinoma.
If the drug is for a rare disease, it can then be submitted forr anorphan drug designation.
[...] treatment einor rare Kradetermined, the company can den Orphan Drug St.atapply for us.
Icatibant has been grantedorphan drug designationin the United States and the European Union.
In this indication, the active ingredient den Orphan Drug Status received in the US and Europe.
Shortly after, the team met with Eurordis on the
[...] possibilities to file for anOrphan drug designation.
A short time later, the research team met with representatives from Eurordis to find out about the
[...] Possibilities eggner Award of Orphan Drug-Stados to discuss.
In July 2006, KBPA 101 has
[...] already receivedOrphan drug designationfrom the European [...]
Already in July 2006 the
[...] product KBPA 101 der "Orphan drug "-Design / Ation through the [...]
European Commission granted.
[...] that a drug is given anOrphan drug designationand later on is authorized [...]
to be distributed in the market has
[...]
obvious implications for those who might benefit from it.
The fact, theress eggno substance als Orphat-drug gekennzeichnet will [...]
and later also received marketing approval
[...]
direct impact on the people who benefit from it.
Six potential Duchenne drugs have
[...] already receivedorphan drug designation:mazindole, oxandrolone, [...]
PTC124, 2'-O-methyl AONs
[...]
for exon skipping, leupeptin, and idebenone.
[...] Duchenne-medication sind already to OrpHan Drugs erkbeen told: [...]
Mazindol, Oxandrolone, PTC124, 2'OMethyl-AONs
[...]
for exon skipping, leupeptin and idebenone.
In order to obtain tHeOrphan drug designationcOmpanies need to [...]
comply with specific criteria spelled out in the Orphan Drug EU Regulation.
Um the marking asOrphan-drug zu receivedalth, must [...]
the companies meet the criteria set out in the EU regulation on
[...]
Orphan drugs are set.
In 2008 we managed to obtain anOrphan drug designation(conditioning treatment prior to haematopoietic progenitor cell transplantation) for this preparation in Europe and in the USA.
E.ine more onkologiWe occupy a niche with Thiotepa®, which is used for conditioning therapy in bone marrow transplants and in childhood brain tumors. In 2008 it was possible for this preparation in Europe and the USA a Orphan Drug Designation [...] [...]
prior to haematopoietic progenitor cell transplantation).
THeorphan drug designationensee belowres EU market [...]
exclusivity for the drug for a period of ten years following marketing authorization.
D.he Orphan DruG status sIert Marcexclusivity [...]
within dhe European U.Nion for a period of ten years after the
[...]
Issuing a license.
Santhera holds global rights on the use of
[...]
Catena® as a treatment of
[...] LHON and has been grantedorphan drug designationsin the European Union and [...]
Santhera holds the global rights to Catena® for the treatment of LHON
[...] and bitnow either in Eurgrandpa as well as in the USA den orphan-Drug-Status.
Moreover, afterOrphan drug designation,E.lafin may enjoy a simplified, expedited and cheaper drug approval procedure as well as EMEAs regulatory guidance in the clinical development process until drug approval.
In addition, once the status has been granted for Elafin, a simplified, accelerated and more cost-effective approval process as well as the advisory support of the EMEA can be used up to approval as a medicinal product.